The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Total Hip Femoral Heads And Liners.
| Device ID | K022958 |
| 510k Number | K022958 |
| Device Name: | TOTAL HIP FEMORAL HEADS AND LINERS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Kim Kelly |
| Correspondent | Kim Kelly SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | JDI |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-06 |
| Decision Date | 2002-10-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556689394 | K022958 | 000 |
| 03596010498205 | K022958 | 000 |
| 03596010498199 | K022958 | 000 |
| 03596010498182 | K022958 | 000 |
| 03596010483799 | K022958 | 000 |
| 03596010477293 | K022958 | 000 |
| 03596010477286 | K022958 | 000 |
| 03596010477279 | K022958 | 000 |
| 03596010000675 | K022958 | 000 |