The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for Lima 28mm Ceramic Head, Modification.
| Device ID | K912985 |
| 510k Number | K912985 |
| Device Name: | LIMA 28MM CERAMIC HEAD, MODIFICATION |
| 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 | Douglas W Stuart |
| Correspondent | Douglas 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 | 1991-07-02 |
| Decision Date | 1991-12-24 |