Arthrex Manufacturing Inc.

Contract manufacturer and sterilizer · Pendleton, SC

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

1994Product codes first listed, by year (tallest: 12)2026

FDA registration: 3015231789 (openFDA record; or search FDA's registration database)
FEI number: 3015231789
Registered for: FDA registration year 2026
Establishment types: Manufacturer; Contract manufacturer; Contract sterilizer
Owner or operator: ARTHREX, INC. (FDA owner/operator no. 1220287)
Registered address: 130 Arthrex Drive, Pendleton, SC 29670
Contract listings: 262 device listings, 79 product codes, first listed Jan 27, 1994
Certification: Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product code	Device (FDA name)	Class	Category	Role	First listed
CCX	Support, Patient Position	Class I	Anesthesiology	Contract manufacturing	Jun 12, 2023
CCX	Support, Patient Position	Class I	Anesthesiology	Contract sterilization	Jun 12, 2023
EBW	Controller, Foot, Handpiece And Cord	Class I	Dental	Contract manufacturing	Sep 9, 2021
EBW	Controller, Foot, Handpiece And Cord	Class I	Dental	Contract sterilization	Sep 9, 2021
EQH	Source, Carrier, Fiberoptic Light	Class I	Ear, nose and throat	Contract manufacturing	Aug 29, 2024
EQH	Source, Carrier, Fiberoptic Light	Class I	Ear, nose and throat	Contract sterilization	Aug 29, 2024
FEI	Instrument, Special Lens, For Endoscope	Class I	Gastroenterology and urology	Contract manufacturing	Jan 25, 2017
FEI	Instrument, Special Lens, For Endoscope	Class I	Gastroenterology and urology	Contract sterilization	Jan 25, 2017
FLE	Sterilizer, Steam	Class II	General hospital	Contract manufacturing	Oct 15, 2024
FLE	Sterilizer, Steam	Class II	General hospital	Contract sterilization	Oct 15, 2024
FMF	Syringe, Piston	Class II	General hospital	Contract manufacturing	Aug 23, 2007
FMF	Syringe, Piston	Class II	General hospital	Contract sterilization	Aug 23, 2007
FMP	Protector, Skin Pressure	Class I	General hospital	Contract manufacturing	Aug 30, 2021
FMP	Protector, Skin Pressure	Class I	General hospital	Contract sterilization	Aug 30, 2021
FRG	Wrap, Sterilization	Class II	General hospital	Contract manufacturing	Oct 15, 2024
FRG	Wrap, Sterilization	Class II	General hospital	Contract sterilization	Oct 15, 2024
FSM	Tray, Surgical, Instrument	Class I	General and plastic surgery	Contract manufacturing	Aug 7, 1996
FSM	Tray, Surgical, Instrument	Class I	General and plastic surgery	Contract sterilization	Aug 7, 1996
FST	Light, Surgical, Fiberoptic	Class II	General and plastic surgery	Contract manufacturing	Sep 13, 2021
FST	Light, Surgical, Fiberoptic	Class II	General and plastic surgery	Contract sterilization	Sep 13, 2021
FTL	Mesh, Surgical, Polymeric	Class II	General and plastic surgery	Contract manufacturing	May 30, 2025
FTL	Mesh, Surgical, Polymeric	Class II	General and plastic surgery	Contract sterilization	May 30, 2025
FXR	Holder, Camera, Surgical	Class I	General and plastic surgery	Contract manufacturing	Nov 19, 2025
FXR	Holder, Camera, Surgical	Class I	General and plastic surgery	Contract sterilization	Nov 19, 2025
GAB	Needle, Suturing, Disposable	Class I	General and plastic surgery	Contract manufacturing	Jan 27, 1994
GAP	Suture, Nonabsorbable, Silk	Class II	General and plastic surgery	Contract manufacturing	Nov 26, 2008
GAP	Suture, Nonabsorbable, Silk	Class II	General and plastic surgery	Contract sterilization	Nov 26, 2008
GAS	Suture, Nonabsorbable, Synthetic, Polyester	Class II	General and plastic surgery	Contract manufacturing	Nov 26, 2008
GAS	Suture, Nonabsorbable, Synthetic, Polyester	Class II	General and plastic surgery	Contract sterilization	Nov 26, 2008
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	Class II	General and plastic surgery	Contract manufacturing	Nov 26, 2008
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	Class II	General and plastic surgery	Contract sterilization	Nov 26, 2008
GBX	Catheter, Irrigation	Class I	General and plastic surgery	Contract manufacturing	Dec 5, 2023
GBX	Catheter, Irrigation	Class I	General and plastic surgery	Contract sterilization	Dec 5, 2023
GCJ	Laparoscope, General & Plastic Surgery	Class II	Gastroenterology and urology	Contract manufacturing	Jul 5, 2019
GCJ	Laparoscope, General & Plastic Surgery	Class II	Gastroenterology and urology	Contract sterilization	Jul 23, 2021
GEI	Electrosurgical, Cutting & Coagulation & Accessories	Class II	General and plastic surgery	Contract manufacturing	Nov 26, 2008
GEI	Electrosurgical, Cutting & Coagulation & Accessories	Class II	General and plastic surgery	Contract sterilization	Nov 26, 2008
HAB	Saw, Powered, And Accessories	Class I	General and plastic surgery	Contract manufacturing	Dec 27, 1994
HRS	Plate, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Nov 26, 2008
HRS	Plate, Fixation, Bone	Class II	Orthopedic	Contract sterilization	Nov 26, 2008
HRX	Arthroscope	Class II	Orthopedic	Contract manufacturing	Jul 31, 2008
HRX	Arthroscope	Class II	Orthopedic	Contract sterilization	Jul 31, 2008
HSB	Rod, Fixation, Intramedullary And Accessories	Class II	Orthopedic	Contract manufacturing	Jul 28, 2017
HSB	Rod, Fixation, Intramedullary And Accessories	Class II	Orthopedic	Contract sterilization	Jul 28, 2017
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Class II	Orthopedic	Contract manufacturing	Dec 2, 2015
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Class II	Orthopedic	Contract sterilization	Apr 27, 2016
HST	Apparatus, Traction, Non-Powered	Class I	Orthopedic	Contract manufacturing	Aug 23, 2007
HST	Apparatus, Traction, Non-Powered	Class I	Orthopedic	Contract sterilization	Aug 23, 2007
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Oct 17, 2011
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract sterilization	Apr 18, 2016
HTC	Pliers, Surgical	Class I	General and plastic surgery	Contract manufacturing	Aug 29, 2024
HTC	Pliers, Surgical	Class I	General and plastic surgery	Contract sterilization	Aug 29, 2024
HTD	Forceps	Class I	General and plastic surgery	Contract manufacturing	Aug 7, 2003
HTJ	Gauge, Depth	Class I	Orthopedic	Contract manufacturing	Jul 13, 2001
HTJ	Gauge, Depth	Class I	Orthopedic	Contract sterilization	Jul 13, 2001
HTN	Washer, Bolt Nut	Class II	Orthopedic	Contract manufacturing	Aug 23, 2007
HTN	Washer, Bolt Nut	Class II	Orthopedic	Contract sterilization	Aug 23, 2007
HTO	Reamer	Class I	Orthopedic	Contract manufacturing	Jan 27, 1994
HTO	Reamer	Class I	Orthopedic	Contract sterilization	Jan 27, 1994
HTW	Bit, Drill	Class I	Orthopedic	Contract manufacturing	Aug 23, 2007
HTW	Bit, Drill	Class I	Orthopedic	Contract sterilization	Aug 23, 2007
HTY	Pin, Fixation, Smooth	Class II	Orthopedic	Contract manufacturing	Aug 23, 2007
HTY	Pin, Fixation, Smooth	Class II	Orthopedic	Contract sterilization	Aug 23, 2007
HTZ	Instrument, Cutting, Orthopedic	Class I	General and plastic surgery	Contract manufacturing	Aug 7, 1996
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Aug 23, 2007
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract sterilization	Aug 23, 2007
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	Class I	General and plastic surgery	Contract manufacturing	Aug 7, 1996
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	Class I	General and plastic surgery	Contract sterilization	Aug 7, 1996
HWR	Driver, Prosthesis	Class I	Orthopedic	Contract manufacturing	Aug 29, 2024
HWR	Driver, Prosthesis	Class I	Orthopedic	Contract sterilization	Aug 29, 2024
HWT	Template	Class I	Orthopedic	Contract manufacturing	Aug 21, 2014
HWT	Template	Class I	Orthopedic	Contract sterilization	Aug 21, 2014
HXB	Probe	Class I	Orthopedic	Contract manufacturing	Aug 7, 2003
HXB	Probe	Class I	Orthopedic	Contract sterilization	Aug 7, 2003
HXC	Wrench	Class I	Orthopedic	Contract manufacturing	Aug 29, 2024
HXC	Wrench	Class I	Orthopedic	Contract sterilization	Aug 29, 2024
HXJ	Staple Driver	Class I	Orthopedic	Contract manufacturing	Nov 26, 2008
HXJ	Staple Driver	Class I	Orthopedic	Contract sterilization	Nov 26, 2008
HXL	Mallet	Class I	General and plastic surgery	Contract manufacturing	Aug 29, 2024
HXL	Mallet	Class I	General and plastic surgery	Contract sterilization	Aug 29, 2024
HXS	Twister, Wire	Class I	Orthopedic	Contract manufacturing	Aug 29, 2024
HXS	Twister, Wire	Class I	Orthopedic	Contract sterilization	Aug 29, 2024
IZI	System, X-Ray, Angiographic	Class II	Radiology	Contract manufacturing	Jul 23, 2021
IZI	System, X-Ray, Angiographic	Class II	Radiology	Contract sterilization	Jul 23, 2021
JDQ	Cerclage, Fixation	Class II	Orthopedic	Contract manufacturing	Nov 15, 2017
JDQ	Cerclage, Fixation	Class II	Orthopedic	Contract sterilization	Nov 15, 2017
JDR	Staple, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Aug 23, 2007
JDR	Staple, Fixation, Bone	Class II	Orthopedic	Contract sterilization	Aug 23, 2007
JDW	Pin, Fixation, Threaded	Class II	Orthopedic	Contract manufacturing	Oct 24, 2023
JDW	Pin, Fixation, Threaded	Class II	Orthopedic	Contract sterilization	Oct 24, 2023
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Class I	Clinical chemistry	Contract manufacturing	Jan 24, 2017
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Class I	Clinical chemistry	Contract sterilization	Jan 24, 2017
JQO	Balance, Analytical	Class I	Clinical chemistry	Contract manufacturing	Aug 3, 2023
JQO	Balance, Analytical	Class I	Clinical chemistry	Contract sterilization	Aug 3, 2023
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Oct 17, 2011
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract sterilization	Feb 8, 2022
KGS	Retention Device, Suture	Class I	General and plastic surgery	Contract manufacturing	Nov 26, 2008
KGS	Retention Device, Suture	Class I	General and plastic surgery	Contract sterilization	Nov 26, 2008
KNW	Instrument, Biopsy	Class II	Gastroenterology and urology	Contract manufacturing	Nov 19, 2021
KNW	Instrument, Biopsy	Class II	Gastroenterology and urology	Contract sterilization	Nov 19, 2021
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Oct 17, 2011
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract sterilization	Apr 18, 2016
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Class II	Orthopedic	Contract manufacturing	Oct 24, 2023
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Class II	Orthopedic	Contract sterilization	Oct 24, 2023
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Class II	Orthopedic	Contract manufacturing	Dec 2, 2015
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Class II	Orthopedic	Contract sterilization	Sep 1, 2016
LLZ	System, Image Processing, Radiological	Class II	Radiology	Contract manufacturing	May 18, 2018
LLZ	System, Image Processing, Radiological	Class II	Radiology	Contract sterilization	Mar 9, 2023
LRY	Punch, Surgical	Class I	General and plastic surgery	Contract manufacturing	Aug 7, 2003
LRY	Punch, Surgical	Class I	General and plastic surgery	Contract sterilization	Aug 7, 2003
LXH	Orthopedic Manual Surgical Instrument	Class I	Orthopedic	Contract manufacturing	Aug 23, 2007
LXH	Orthopedic Manual Surgical Instrument	Class I	Orthopedic	Contract sterilization	Aug 23, 2007
LXI	Guide, Drill, Ligament	Class I	General and plastic surgery	Contract manufacturing	Feb 27, 2018
LXI	Guide, Drill, Ligament	Class I	General and plastic surgery	Contract sterilization	Feb 27, 2018
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Class II	Orthopedic	Contract manufacturing	Aug 23, 2007
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Class II	Orthopedic	Contract sterilization	Aug 23, 2007
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Class II	Orthopedic	Contract manufacturing	Oct 5, 2018
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Class II	Orthopedic	Contract sterilization	Oct 5, 2018
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Feb 24, 2016
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Class II	Orthopedic	Contract sterilization	Mar 29, 2018
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Class II	Orthopedic	Contract manufacturing	Aug 23, 2007
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Class II	Orthopedic	Contract sterilization	Aug 23, 2007
MBP	Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)	Class II	Orthopedic	Contract manufacturing	Dec 23, 2013
MDM	Instrument, Manual, Surgical, General Use	Class I	General and plastic surgery	Contract manufacturing	Aug 23, 2007
MDM	Instrument, Manual, Surgical, General Use	Class I	General and plastic surgery	Contract sterilization	Aug 23, 2007
MHW	Dressing, Compression	Class I	General hospital	Contract manufacturing	Jan 8, 2014
MNU	Staple, Absorbable	Class II	Orthopedic	Contract manufacturing	Nov 26, 2008
MNU	Staple, Absorbable	Class II	Orthopedic	Contract sterilization	Nov 26, 2008
MQV	Filler, Bone Void, Calcium Compound	Class II	Orthopedic	Contract manufacturing	Nov 26, 2008
MRW	System, Facet Screw Spinal Device	Unclassified	Orthopedic	Contract manufacturing	May 23, 2025
MRW	System, Facet Screw Spinal Device	Unclassified	Orthopedic	Contract sterilization	May 23, 2025
NBH	Accessories, Arthroscopic	Class I	Orthopedic	Contract manufacturing	Aug 23, 2007
NBH	Accessories, Arthroscopic	Class I	Orthopedic	Contract sterilization	Aug 23, 2007
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Class II	Orthopedic	Contract manufacturing	Feb 24, 2016
ORG	Platelet And Plasma Separator For Bone Graft Handling	Class II	Hematology	Contract manufacturing	Jul 31, 2018
ORG	Platelet And Plasma Separator For Bone Graft Handling	Class II	Hematology	Contract sterilization	Jul 31, 2018
OWN	Confocal Optical Imaging	Class II	Gastroenterology and urology	Contract manufacturing	Nov 19, 2025
OWN	Confocal Optical Imaging	Class II	Gastroenterology and urology	Contract sterilization	Nov 19, 2025
OWX	Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon	Class II	General and plastic surgery	Contract manufacturing	May 30, 2025
OWX	Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon	Class II	General and plastic surgery	Contract sterilization	May 30, 2025
OWY	Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon	Class II	General and plastic surgery	Contract manufacturing	Nov 19, 2025
OWY	Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon	Class II	General and plastic surgery	Contract sterilization	Nov 19, 2025
PHX	Shoulder Prosthesis, Reverse Configuration	Class II	Orthopedic	Contract manufacturing	Feb 9, 2015
PHX	Shoulder Prosthesis, Reverse Configuration	Class II	Orthopedic	Contract sterilization	Feb 9, 2015
PLF	Bone Wedge	Class II	Orthopedic	Contract manufacturing	Dec 31, 2015
PLF	Bone Wedge	Class II	Orthopedic	Contract sterilization	Dec 31, 2015
PUI	Drape, Surgical, Exempt	Class II	General and plastic surgery	Contract manufacturing	Mar 28, 2024
PUI	Drape, Surgical, Exempt	Class II	General and plastic surgery	Contract sterilization	Mar 28, 2024
QHE	Shoulder Arthroplasty Implantation System	Class II	Orthopedic	Contract manufacturing	Mar 9, 2023
QHE	Shoulder Arthroplasty Implantation System	Class II	Orthopedic	Contract sterilization	Mar 9, 2023

Arthrex Manufacturing Inc.

Devices listed as contract work

Other contract facilities of ARTHREX, INC.