The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for Link Saddle Prothesis.
| Device ID | K951355 |
| 510k Number | K951355 |
| Device Name: | LINK SADDLE PROTHESIS |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| 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 | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-08 |
| Decision Date | 1995-05-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026575047840 | K951355 | 000 |
| 04026575047765 | K951355 | 000 |