The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for Universal Wrist.
| Device ID | K940297 |
| 510k Number | K940297 |
| Device Name: | UNIVERSAL WRIST |
| Classification | Prosthesis, Wrist, 2 Part Metal-plastic Articulation, Semi-constrained |
| Applicant | TURNKEY INTERGRATION USA, INC. 6060 CASTLEWAY DR. WEST SUITE 236 Indianapolis, IN 46250 -1290 |
| Contact | Douglas W Stuart |
| Correspondent | Douglas W Stuart TURNKEY INTERGRATION USA, INC. 6060 CASTLEWAY DR. WEST SUITE 236 Indianapolis, IN 46250 -1290 |
| Product Code | JWI |
| CFR Regulation Number | 888.3800 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-21 |
| Decision Date | 1995-02-06 |