Contract manufacturerRESTORATION MEDICAL POLYMERS (Columbia City, IN)IndianaOrthopedicClass II
RESTORATION MEDICAL POLYMERS
Contract manufacturer · Columbia City, IN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3015916578 (openFDA record; or search FDA's registration database)
- FEI number
- 3015916578
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- Restoration Medical Polymers (FDA owner/operator no. 10078694)
- Registered address
- 4474 East Park 30 Drive, Columbia City, IN 46725
- Contract listings
- 5 device listings, 11 product codes, first listed Nov 2, 2020
- 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 |
|---|---|---|---|---|---|
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Nov 2, 2020 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Class II | Orthopedic | Contract manufacturing | Dec 9, 2022 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Nov 2, 2020 |
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | Class II | Orthopedic | Contract manufacturing | Nov 2, 2021 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | Dec 9, 2022 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Class II | Orthopedic | Contract manufacturing | Dec 9, 2022 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | Class II | Orthopedic | Contract manufacturing | Dec 9, 2022 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Nov 2, 2020 |
| MBV | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Nov 2, 2020 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Class II | Orthopedic | Contract manufacturing | Nov 2, 2020 |
| PAO | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | Class II | Orthopedic | Contract manufacturing | Dec 9, 2022 |