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 |