The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Total Hip Femoral Head - 12/14 Taper.
| Device ID | K021673 |
| 510k Number | K021673 |
| Device Name: | TOTAL HIP FEMORAL HEAD - 12/14 TAPER |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| 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 | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-21 |
| Decision Date | 2002-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010537492 | K021673 | 000 |
| 03596010474155 | K021673 | 000 |
| 03596010474148 | K021673 | 000 |
| 03596010439420 | K021673 | 000 |
| 03596010439390 | K021673 | 000 |
| 03596010439383 | K021673 | 000 |
| 03596010434678 | K021673 | 000 |
| 03596010434661 | K021673 | 000 |
| 03596010434654 | K021673 | 000 |
| 03596010430816 | K021673 | 000 |
| 03596010430199 | K021673 | 000 |
| 03596010430182 | K021673 | 000 |
| 03596010430175 | K021673 | 000 |
| 03596010430168 | K021673 | 000 |
| 03596010430151 | K021673 | 000 |
| 03596010430144 | K021673 | 000 |
| 03596010439413 | K021673 | 000 |
| 03596010474162 | K021673 | 000 |
| 03596010474179 | K021673 | 000 |
| 03596010525185 | K021673 | 000 |
| 03596010520449 | K021673 | 000 |
| 03596010516275 | K021673 | 000 |
| 03596010514233 | K021673 | 000 |
| 03596010488916 | K021673 | 000 |
| 03596010488909 | K021673 | 000 |
| 03596010488893 | K021673 | 000 |
| 03596010488886 | K021673 | 000 |
| 03596010488879 | K021673 | 000 |
| 03596010488862 | K021673 | 000 |
| 03596010474230 | K021673 | 000 |
| 03596010474223 | K021673 | 000 |
| 03596010474216 | K021673 | 000 |
| 03596010474209 | K021673 | 000 |
| 03596010474193 | K021673 | 000 |
| 03596010474186 | K021673 | 000 |
| 03596010511430 | K021673 | 000 |