The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for Nuffield Total Knee.
| Device ID | K931960 |
| 510k Number | K931960 |
| Device Name: | NUFFIELD TOTAL KNEE |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | TURNKEY INTERGRATION USA, INC. 8021 KNUE RD. SUITE 121 Indianapolis, IN 46250 |
| Contact | Douglas Stuart |
| Correspondent | Douglas Stuart TURNKEY INTERGRATION USA, INC. 8021 KNUE RD. SUITE 121 Indianapolis, IN 46250 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-21 |
| Decision Date | 1994-10-07 |