Contract manufacturerAVALIGN INTEGRATED MEDICAL SOLUTIONS, INC (Mentor, OH)OhioOrthopedicPhysical medicineClass IIClass I
AVALIGN INTEGRATED MEDICAL SOLUTIONS, INC
Contract manufacturer ยท Mentor, OH
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1527105 (openFDA record; or search FDA's registration database)
- FEI number
- 1000069183
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Avalign Technologies (FDA owner/operator no. 10051835)
- Registered address
- 7124 Industrial Park Blvd, Mentor, OH 44060
- Contract listings
- 23 device listings, 15 product codes, first listed Jun 22, 2019
- 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 |
|---|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Jun 22, 2019 |
| HTN | Washer, Bolt Nut | Class II | Orthopedic | Contract manufacturing | Jun 22, 2019 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Jun 22, 2019 |
| IQK | Orthosis, Cervical | Class I | Physical medicine | Contract manufacturing | Jun 22, 2019 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Jun 22, 2019 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract manufacturing | Jun 22, 2019 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract manufacturing | Jul 25, 2025 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Class II | Orthopedic | Contract manufacturing | Jun 22, 2019 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract manufacturing | Jun 22, 2019 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract manufacturing | Jun 22, 2019 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract manufacturing | Jun 22, 2019 |
| NKG | Posterior Cervical Screw System | Class II | Orthopedic | Contract manufacturing | Jan 30, 2026 |
| OBT | Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | Class II | Orthopedic | Contract manufacturing | Jun 22, 2019 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | Contract manufacturing | Jul 25, 2025 |
| OWI | Bone Fixation Cerclage, Sublaminar | Class II | Orthopedic | Contract manufacturing | Jan 30, 2026 |