The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Taper Oxinium Femoral Head.
| Device ID | K110101 |
| 510k Number | K110101 |
| Device Name: | TAPER OXINIUM FEMORAL HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Shereen Myers |
| Correspondent | Shereen Myers SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-13 |
| Decision Date | 2011-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556533895 | K110101 | 000 |
| 00885556112441 | K110101 | 000 |
| 00885556112458 | K110101 | 000 |
| 00885556112465 | K110101 | 000 |
| 00885556112472 | K110101 | 000 |
| 00885556112489 | K110101 | 000 |
| 00885556112496 | K110101 | 000 |
| 00885556112502 | K110101 | 000 |
| 00885556112519 | K110101 | 000 |
| 00885556112526 | K110101 | 000 |
| 00885556112533 | K110101 | 000 |
| 00885556112540 | K110101 | 000 |
| 00885556533802 | K110101 | 000 |
| 00885556533888 | K110101 | 000 |
| 00885556112434 | K110101 | 000 |