The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Hydroxylapatite Coated Ti-fit Femoral Component.
| Device ID | K913916 |
| 510k Number | K913916 |
| Device Name: | HYDROXYLAPATITE COATED TI-FIT FEMORAL COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Robert F Games |
| Correspondent | Robert F Games SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-03 |
| Decision Date | 1991-12-09 |