PARAGON MEDICAL, INC.

Contract manufacturer · Pierceton, IN

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

1994Product codes first listed, by year (tallest: 62)2026

FDA registration: 1834331 (openFDA record; or search FDA's registration database)
FEI number: 1000306340
Registered for: FDA registration year 2026
Establishment types: Manufacturer; Contract manufacturer
Owner or operator: Paragon Medical (FDA owner/operator no. 9011072)
Registered address: 8 Matchett Dr., Pierceton, IN 46562
Contract listings: 136 device listings, 114 product codes, first listed Jul 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
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Class II	Ear, nose and throat	Contract manufacturing	Dec 18, 2024
FSM	Tray, Surgical, Instrument	Class I	General and plastic surgery	Contract manufacturing	Jul 27, 1994
FZT	Cutter, Surgical	Class I	General and plastic surgery	Contract manufacturing	Jan 17, 2013
FZX	Guide, Surgical, Instrument	Class I	General and plastic surgery	Contract manufacturing	Jan 17, 2013
GAD	Retractor	Class I	General and plastic surgery	Contract manufacturing	Jan 30, 2013
GEY	Motor, Surgical Instrument, Ac-Powered	Class I	General and plastic surgery	Contract manufacturing	Jan 17, 2013
GFA	Blade, Saw, General & Plastic Surgery, Surgical	Class I	General and plastic surgery	Contract manufacturing	Jan 15, 2020
GZT	Retractor, Self-Retaining, For Neurosurgery	Class II	Neurology	Contract manufacturing	Jan 30, 2013
HAW	Neurological Stereotaxic Instrument	Class II	Neurology	Contract manufacturing	Jan 17, 2013
HBB	Motor, Drill, Pneumatic	Class II	Neurology	Contract manufacturing	Jan 18, 2013
HBC	Motor, Drill, Electric	Class II	Neurology	Contract manufacturing	Jan 18, 2013
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Class II	Neurology	Contract manufacturing	Jan 18, 2013
HRS	Plate, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Mar 16, 2016
HRX	Arthroscope	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
HRY	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
HSB	Rod, Fixation, Intramedullary And Accessories	Class II	Orthopedic	Contract manufacturing	Feb 4, 2013
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Class II	Orthopedic	Contract manufacturing	Jan 13, 2016
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Jan 29, 2019
HST	Apparatus, Traction, Non-Powered	Class I	Orthopedic	Contract manufacturing	Jan 17, 2013
HSX	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
HSZ	Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment	Class I	General and plastic surgery	Contract manufacturing	Jan 18, 2013
HTJ	Gauge, Depth	Class I	Orthopedic	Contract manufacturing	Jan 17, 2013
HTO	Reamer	Class I	Orthopedic	Contract manufacturing	Jan 17, 2013
HTQ	Broach	Class I	Orthopedic	Contract manufacturing	Jan 17, 2013
HTR	Rasp	Class I	General and plastic surgery	Contract manufacturing	Jan 17, 2013
HTW	Bit, Drill	Class I	Orthopedic	Contract manufacturing	Jan 30, 2013
HTY	Pin, Fixation, Smooth	Class II	Orthopedic	Contract manufacturing	Nov 22, 2017
HTZ	Instrument, Cutting, Orthopedic	Class I	General and plastic surgery	Contract manufacturing	May 31, 2017
HWA	Impactor	Class I	Orthopedic	Contract manufacturing	Jan 30, 2013
HWB	Extractor	Class I	Orthopedic	Contract manufacturing	Jan 30, 2013
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Mar 16, 2016
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	Class I	General and plastic surgery	Contract manufacturing	Jan 18, 2013
HWJ	Awl	Class I	Orthopedic	Contract manufacturing	Oct 14, 2008
HWM	Osteotome	Class I	General and plastic surgery	Contract manufacturing	Jan 30, 2013
HWR	Driver, Prosthesis	Class I	Orthopedic	Contract manufacturing	Jan 20, 2013
HWT	Template	Class I	Orthopedic	Contract manufacturing	Jan 20, 2013
HWX	Tap, Bone	Class I	Orthopedic	Contract manufacturing	Jan 30, 2013
HXC	Wrench	Class I	Orthopedic	Contract manufacturing	Dec 13, 2016
HXD	Clamp	Class I	General and plastic surgery	Contract manufacturing	Jan 30, 2013
HXG	Tamp	Class I	Orthopedic	Contract manufacturing	Jan 30, 2013
HXP	Instrument, Bending Or Contouring	Class I	Orthopedic	Contract manufacturing	Jul 7, 2021
HXX	Screwdriver	Class I	Orthopedic	Contract manufacturing	Jan 20, 2013
JDB	Prosthesis, Elbow, Semi-Constrained, Cemented	Class II	Orthopedic	Contract manufacturing	Mar 16, 2016
JDC	Prosthesis, Elbow, Constrained, Cemented	Class II	Orthopedic	Contract manufacturing	Jun 21, 2018
JDG	Prosthesis, Hip, Femoral Component, Cemented, Metal	Class II	Orthopedic	Contract manufacturing	Jun 15, 2020
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Class II	Orthopedic	Contract manufacturing	Jan 13, 2016
JDJ	Mesh, Surgical, Acetabular, Hip, Prosthesis	Class II	General and plastic surgery	Contract manufacturing	Jun 15, 2020
JDQ	Cerclage, Fixation	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
JDS	Nail, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Feb 4, 2013
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	Class II	General hospital	Contract manufacturing	Feb 6, 2013
KFK	Saw, Pneumatically Powered	Class I	General and plastic surgery	Contract manufacturing	Jan 18, 2013
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	Class I	General and plastic surgery	Contract manufacturing	May 11, 2022
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
KRQ	Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Class II	Orthopedic	Contract manufacturing	Dec 11, 2013
KWG	Prosthesis, Finger, Constrained, Metal/Polymer	Class III	Orthopedic	Contract manufacturing	Mar 16, 2016
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Class II	Orthopedic	Contract manufacturing	Mar 16, 2016
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Class II	Orthopedic	Contract manufacturing	Nov 10, 2015
KWP	Appliance, Fixation, Spinal Interlaminal	Class II	Orthopedic	Contract manufacturing	Jan 17, 2013
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Class II	Orthopedic	Contract manufacturing	Jan 17, 2013
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Class II	Orthopedic	Contract manufacturing	Jan 13, 2016
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Class II	Orthopedic	Contract manufacturing	Jan 13, 2016
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Class II	Orthopedic	Contract manufacturing	Nov 10, 2015
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Jan 13, 2016
KXE	Prosthesis, Wrist, Hemi-, Ulnar	Class II	Orthopedic	Contract manufacturing	Mar 16, 2016
KYJ	Prosthesis, Finger, Constrained, Polymer	Class II	Orthopedic	Contract manufacturing	Mar 16, 2016
LLZ	System, Image Processing, Radiological	Class II	Radiology	Contract manufacturing	Jan 17, 2013
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Class II	Orthopedic	Contract manufacturing	Oct 24, 2013
LRC	Instrument, Ent Manual Surgical	Class I	Ear, nose and throat	Contract manufacturing	Jan 18, 2013
LRP	Tray, Surgical	Class I	General and plastic surgery	Contract manufacturing	Jan 18, 2013
LRY	Punch, Surgical	Class I	General and plastic surgery	Contract manufacturing	May 5, 2016
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Class II	Orthopedic	Contract manufacturing	Jun 15, 2020
LXH	Orthopedic Manual Surgical Instrument	Class I	Orthopedic	Contract manufacturing	Dec 28, 2007
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	Class II	Orthopedic	Contract manufacturing	Dec 14, 2015
LYS	Bone Mill	Class I	Orthopedic	Contract manufacturing	Sep 13, 2024
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
LZY	Prosthesis, Hip, Hemi-, Femoral, Metal Ball	Class II	Orthopedic	Contract manufacturing	Jun 15, 2020
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Class II	Orthopedic	Contract manufacturing	Jun 12, 2025
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Class II	Orthopedic	Contract manufacturing	Jan 17, 2013
MAY	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	Class II	Orthopedic	Contract manufacturing	Oct 24, 2013
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Class II	Orthopedic	Contract manufacturing	Jan 15, 2020
MBH	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Class II	Orthopedic	Contract manufacturing	Jun 12, 2025
MBL	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	Class II	Orthopedic	Contract manufacturing	Oct 24, 2013
MDM	Instrument, Manual, Surgical, General Use	Class I	General and plastic surgery	Contract manufacturing	Oct 14, 2008
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
MJO	Prosthesis, Intervertebral Disc	Class III	Orthopedic	Contract manufacturing	Jan 30, 2013
MMO	Tray, Surgical, Ent	Class I	Ear, nose and throat	Contract manufacturing	Jan 18, 2013
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Class II	Orthopedic	Contract manufacturing	Jan 17, 2013
MNI	Orthosis, Spinal Pedicle Fixation	Class II	Orthopedic	Contract manufacturing	Jan 17, 2013
MPK	Semi-Constrained Metal/Polymer Finger Joint Prosthesis	HDE	Orthopedic	Contract manufacturing	Mar 16, 2016
MQP	Spinal Vertebral Body Replacement Device	Class II	Orthopedic	Contract manufacturing	Jan 17, 2013
NBH	Accessories, Arthroscopic	Class I	Orthopedic	Contract manufacturing	Jan 30, 2013
NDL	Pin, Fixation, Smooth, Metallic	Class II	Orthopedic	Contract manufacturing	Feb 5, 2026
NDP	Accessories, Implant, Dental, Endosseous	Class I	Dental	Contract manufacturing	Jan 29, 2018
NJL	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing	Class III	Orthopedic	Contract manufacturing	Jul 18, 2016
NKB	Thoracolumbosacral Pedicle Screw System	Class II	Orthopedic	Contract manufacturing	Nov 10, 2023
NPJ	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
NXT	Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing	Class III	Orthopedic	Contract manufacturing	Dec 16, 2015
OBT	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis	Class II	Orthopedic	Contract manufacturing	Nov 9, 2018
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Class II	Orthopedic	Contract manufacturing	Jan 17, 2013
OIY	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	Class II	Orthopedic	Contract manufacturing	Nov 6, 2018
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	Contract manufacturing	Nov 10, 2023
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
OSN	Software For Diagnosis/Treatment	Class II	Orthopedic	Contract manufacturing	Nov 9, 2018
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Class II	Orthopedic	Contract manufacturing	Jan 17, 2013
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Class II	Orthopedic	Contract manufacturing	Jan 18, 2013
PAO	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	Class II	Orthopedic	Contract manufacturing	Jan 28, 2016
PHX	Shoulder Prosthesis, Reverse Configuration	Class II	Orthopedic	Contract manufacturing	Jan 16, 2020
PKC	Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Class II	Orthopedic	Contract manufacturing	May 9, 2025
PML	Bone Cement, Posterior Screw Augmentation	Class II	Orthopedic	Contract manufacturing	Nov 19, 2025
QBO	Instruments Designed For Press-Fit Osteochondral Implants	Class II	Orthopedic	Contract manufacturing	Jul 29, 2022

PARAGON MEDICAL, INC.

Devices listed as contract work

Other contract facilities of Paragon Medical