Contract manufacturerMack Proto (Gardner, MA)MassachusettsOrthopedicClass IClass II
Mack Proto
Contract manufacturer · Gardner, MA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3005279746 (openFDA record; or search FDA's registration database)
- FEI number
- 3005279746
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- MACK MOLDING COMPANY (FDA owner/operator no. 9040779)
- Registered address
- 424 Main St, Gardner, MA 01440
- Contract listings
- 3 device listings, 3 product codes, first listed Jan 28, 2013
- 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 |
|---|---|---|---|---|---|
| HWT | Template | Class I | Orthopedic | Contract manufacturing | Jan 28, 2013 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jan 31, 2014 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | Contract manufacturing | Jan 31, 2014 |