Avalign Instruments & Implants

Contract manufacturer · Fort Wayne, IN

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

FDA registration: 3006128100 (openFDA record; or search FDA's registration database)
FEI number: 3006128100
Registered for: FDA registration year 2026
Establishment types: Contract manufacturer
Owner or operator: Avalign Instruments & Implants (FDA owner/operator no. 9008280)
Registered address: 8727 Clinton Park Drive, 8414 Clinton Park Drive, Fort Wayne, IN 46825
Contract listings: 162 device listings, 114 product codes, first listed Jan 31, 2007
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
DZJ	Driver, Wire, And Bone Drill, Manual	Class II	Dental	Contract manufacturing	Sep 10, 2023
ETN	Stimulator, Nerve	Class II	Ear, nose and throat	Contract manufacturing	Jan 7, 2014
EZX	Mesh, Surgical, Metal	Class II	General and plastic surgery	Contract manufacturing	Apr 13, 2017
FGM	Probe And Director, Gastro-Urology	Class I	Gastroenterology and urology	Contract manufacturing	Sep 10, 2023
FSM	Tray, Surgical, Instrument	Class I	General and plastic surgery	Contract manufacturing	Jan 17, 2013
FST	Light, Surgical, Fiberoptic	Class II	General and plastic surgery	Contract manufacturing	Jan 27, 2026
FZO	Chisel, Surgical, Manual	Class I	General and plastic surgery	Contract manufacturing	Jun 1, 2015
FZX	Guide, Surgical, Instrument	Class I	General and plastic surgery	Contract manufacturing	Jan 17, 2013
FZY	Hammer, Surgical	Class I	General and plastic surgery	Contract manufacturing	Jan 17, 2013
GAD	Retractor	Class I	General and plastic surgery	Contract manufacturing	Jul 18, 2011
GBX	Catheter, Irrigation	Class I	General and plastic surgery	Contract manufacturing	Jan 21, 2013
GDG	Hook, Surgical, General & Plastic Surgery	Class I	General and plastic surgery	Contract manufacturing	Sep 10, 2023
GDI	Dissector, Surgical, General & Plastic Surgery	Class I	General and plastic surgery	Contract manufacturing	Jan 21, 2013
GDX	Scalpel, One-Piece	Class I	General and plastic surgery	Contract manufacturing	Jan 21, 2013
GDZ	Handle, Scalpel	Class I	General and plastic surgery	Contract manufacturing	Apr 13, 2017
GEA	Cannula, Surgical, General & Plastic Surgery	Class I	General and plastic surgery	Contract manufacturing	Apr 13, 2017
GED	Brush, Dermabrasion, Manual	Class I	General and plastic surgery	Contract manufacturing	Jan 17, 2013
GEG	Elevator, Surgical, General & Plastic Surgery	Class I	General and plastic surgery	Contract manufacturing	Feb 7, 2021
GFC	Driver, Surgical, Pin	Class I	General and plastic surgery	Contract manufacturing	Jan 21, 2013
GFF	Bur, Surgical, General & Plastic Surgery	Class I	General and plastic surgery	Contract manufacturing	Jan 25, 2013
GFG	Bit, Surgical	Class I	General and plastic surgery	Contract manufacturing	Sep 23, 2015
GFI	Osteotome, Manual	Class I	General and plastic surgery	Contract manufacturing	Sep 10, 2023
GFJ	Mallet, Surgical, General & Plastic Surgery	Class I	General and plastic surgery	Contract manufacturing	Dec 27, 2021
GWF	Stimulator, Electrical, Evoked Response	Class II	Neurology	Contract manufacturing	Jan 7, 2014
HAW	Neurological Stereotaxic Instrument	Class II	Neurology	Contract manufacturing	Apr 13, 2017
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Class II	Neurology	Contract manufacturing	Jun 6, 2024
HRS	Plate, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Nov 28, 2018
HSB	Rod, Fixation, Intramedullary And Accessories	Class II	Orthopedic	Contract manufacturing	Feb 29, 2016
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Class II	Orthopedic	Contract manufacturing	Jan 17, 2013
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Jun 1, 2015
HST	Apparatus, Traction, Non-Powered	Class I	Orthopedic	Contract manufacturing	Jan 21, 2013
HTC	Pliers, Surgical	Class I	General and plastic surgery	Contract manufacturing	Jan 21, 2013
HTD	Forceps	Class I	General and plastic surgery	Contract manufacturing	Jan 21, 2013
HTF	Curette	Class I	General and plastic surgery	Contract manufacturing	Jan 17, 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	Sep 10, 2023
HTR	Rasp	Class I	General and plastic surgery	Contract manufacturing	Jan 17, 2013
HTW	Bit, Drill	Class I	Orthopedic	Contract manufacturing	Jan 17, 2013
HTX	Rongeur	Class I	Orthopedic	Contract manufacturing	Jan 21, 2013
HWA	Impactor	Class I	Orthopedic	Contract manufacturing	Jan 17, 2013
HWB	Extractor	Class I	Orthopedic	Contract manufacturing	Jan 17, 2013
HWC	Screw, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Nov 28, 2018
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	Class I	General and plastic surgery	Contract manufacturing	Aug 13, 2018
HWJ	Awl	Class I	Orthopedic	Contract manufacturing	Jan 17, 2013
HWK	Trephine	Class I	Orthopedic	Contract manufacturing	Jan 17, 2013
HWM	Osteotome	Class I	General and plastic surgery	Contract manufacturing	Jul 18, 2011
HWN	Instrument, Compression	Class I	Orthopedic	Contract manufacturing	Jan 17, 2013
HWR	Driver, Prosthesis	Class I	Orthopedic	Contract manufacturing	Jan 17, 2013
HWT	Template	Class I	Orthopedic	Contract manufacturing	Jul 18, 2011
HWW	Countersink	Class I	Orthopedic	Contract manufacturing	Sep 10, 2023
HWX	Tap, Bone	Class I	Orthopedic	Contract manufacturing	Jan 17, 2013
HXB	Probe	Class I	Orthopedic	Contract manufacturing	Jan 17, 2013
HXC	Wrench	Class I	Orthopedic	Contract manufacturing	Jan 17, 2013
HXD	Clamp	Class I	General and plastic surgery	Contract manufacturing	Jan 17, 2013
HXG	Tamp	Class I	Orthopedic	Contract manufacturing	Jan 21, 2013
HXL	Mallet	Class I	General and plastic surgery	Contract manufacturing	Apr 13, 2017
HXO	Pusher, Socket	Class I	Orthopedic	Contract manufacturing	Jul 28, 2026
HXP	Instrument, Bending Or Contouring	Class I	Orthopedic	Contract manufacturing	Jan 17, 2013
HXQ	Crimper, Pin	Class I	Orthopedic	Contract manufacturing	Apr 13, 2017
HXW	Bender	Class I	Orthopedic	Contract manufacturing	Jan 17, 2013
HXX	Screwdriver	Class I	Orthopedic	Contract manufacturing	Jan 17, 2013
IKN	Electromyograph, Diagnostic	Class II	Physical medicine	Contract manufacturing	Jan 7, 2014
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
JDL	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	Class III	Orthopedic	Contract manufacturing	Jan 31, 2013
JDQ	Cerclage, Fixation	Class II	Orthopedic	Contract manufacturing	Sep 21, 2023
JDS	Nail, Fixation, Bone	Class II	Orthopedic	Contract manufacturing	Jan 21, 2013
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Class II	Orthopedic	Contract manufacturing	May 23, 2016
KDD	Kit, Surgical Instrument, Disposable	Class I	General and plastic surgery	Contract manufacturing	Jan 25, 2013
KIH	Dispenser, Cement	Class I	Orthopedic	Contract manufacturing	Nov 28, 2018
KQW	Goniometer, Nonpowered	Class I	Orthopedic	Contract manufacturing	Jan 21, 2013
KTZ	Caliper	Class I	Orthopedic	Contract manufacturing	Jan 25, 2013
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Class III	Orthopedic	Contract manufacturing	Jan 31, 2013
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Class II	Orthopedic	Contract manufacturing	Jan 21, 2013
KWP	Appliance, Fixation, Spinal Interlaminal	Class II	Orthopedic	Contract manufacturing	Jan 21, 2013
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Class II	Orthopedic	Contract manufacturing	Jan 21, 2013
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Class II	Orthopedic	Contract manufacturing	Jan 17, 2013
KWT	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	Class II	Orthopedic	Contract manufacturing	Jan 17, 2013
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
LRN	Wire, Surgical	Class II	Orthopedic	Contract manufacturing	Apr 11, 2023
LRP	Tray, Surgical	Class I	General and plastic surgery	Contract manufacturing	Jun 1, 2015
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Class II	Orthopedic	Contract manufacturing	Aug 13, 2019
LXH	Orthopedic Manual Surgical Instrument	Class I	Orthopedic	Contract manufacturing	Jan 31, 2007
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
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	Jan 31, 2013
MBF	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Class II	Orthopedic	Contract manufacturing	Jan 28, 2013
MDM	Instrument, Manual, Surgical, General Use	Class I	General and plastic surgery	Contract manufacturing	Jan 17, 2013
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Class II	Orthopedic	Contract manufacturing	Jan 31, 2013
MJO	Prosthesis, Intervertebral Disc	Class III	Orthopedic	Contract manufacturing	Jan 27, 2026
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Class II	Orthopedic	Contract manufacturing	Jan 21, 2013
MNI	Orthosis, Spinal Pedicle Fixation	Class II	Orthopedic	Contract manufacturing	Jan 21, 2013
MQN	External Mandibular Fixator And/Or Distractor	Class II	Dental	Contract manufacturing	Jan 21, 2013
MQP	Spinal Vertebral Body Replacement Device	Class II	Orthopedic	Contract manufacturing	Jan 17, 2013
NBH	Accessories, Arthroscopic	Class I	Orthopedic	Contract manufacturing	Jan 7, 2014
NKB	Thoracolumbosacral Pedicle Screw System	Class II	Orthopedic	Contract manufacturing	Jan 21, 2013
NKG	Posterior Cervical Screw System	Class II	Orthopedic	Contract manufacturing	Jan 26, 2026
NTG	Prosthesis, Ankle, Uncemented, Non-Constrained	Class III	Orthopedic	Contract manufacturing	Jan 29, 2016
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Class II	Orthopedic	Contract manufacturing	Jan 21, 2013
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	Contract manufacturing	Apr 13, 2017
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Class II	Orthopedic	Contract manufacturing	Jan 7, 2014
OUR	Sacroiliac Joint Fixation	Class II	Orthopedic	Contract manufacturing	Aug 19, 2026
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Class II	Orthopedic	Contract manufacturing	Nov 1, 2022
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Class II	Orthopedic	Contract manufacturing	Jan 17, 2013
OWB	Interventional Fluoroscopic X-Ray System	Class II	Radiology	Contract manufacturing	Jan 27, 2026
OWI	Bone Fixation Cerclage, Sublaminar	Class II	Orthopedic	Contract manufacturing	Jan 27, 2026
PDQ	Neurosurgical Nerve Locator	Class II	Ear, nose and throat	Contract manufacturing	Jan 27, 2026
PEK	Spinous Process Plate	Class II	Orthopedic	Contract manufacturing	Jan 26, 2026
PGN	Growing Rod System- Magnetic Actuation	Class II	Orthopedic	Contract manufacturing	Jan 27, 2026
PHX	Shoulder Prosthesis, Reverse Configuration	Class II	Orthopedic	Contract manufacturing	Jul 17, 2026
PLR	Spinal Vertebral Body Replacement Device - Cervical	Class II	Orthopedic	Contract manufacturing	Jan 26, 2026
PML	Bone Cement, Posterior Screw Augmentation	Class II	Orthopedic	Contract manufacturing	Jan 27, 2026

Avalign Instruments & Implants

Devices listed as contract work

Other contract facilities of Avalign Instruments & Implants