Contract manufacturerAvalign Additive / Slice Manufacturing Studios (Akron, OH)OhioOrthopedicClass II
Avalign Additive / Slice Manufacturing Studios
Contract manufacturer ยท Akron, OH
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3013413393 (openFDA record; or search FDA's registration database)
- FEI number
- 3013413393
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Avalign Instruments & Implants (FDA owner/operator no. 9008280)
- Registered address
- 1810 Triplett Blvd, Akron, OH 44306
- Contract listings
- 6 device listings, 10 product codes, first listed Mar 8, 2021
- 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 | Jan 24, 2023 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | Contract manufacturing | Mar 8, 2021 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | Contract manufacturing | Mar 8, 2021 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract manufacturing | Jul 12, 2021 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | Contract manufacturing | Jul 1, 2026 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Class II | Orthopedic | Contract manufacturing | Mar 8, 2021 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | Class II | Orthopedic | Contract manufacturing | Mar 8, 2021 |
| OUR | Sacroiliac Joint Fixation | Class II | Orthopedic | Contract manufacturing | May 18, 2026 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | Contract manufacturing | Jul 28, 2025 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | Contract manufacturing | Jul 1, 2026 |