The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for Feldmuehle Ceramic Head (12/14 X 32mm).
| Device ID | K910548 |
| 510k Number | K910548 |
| Device Name: | FELDMUEHLE CERAMIC HEAD (12/14 X 32MM) |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | TURNKEY INTERGRATION USA, INC. 8021 KNUE RD. SUITE 121 Indianapolis, IN 46250 |
| Contact | D. W Stuart |
| Correspondent | D. W Stuart TURNKEY INTERGRATION USA, INC. 8021 KNUE RD. SUITE 121 Indianapolis, IN 46250 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-07 |
| Decision Date | 1991-04-09 |