The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Synergy Ha Coated Porous Femoral Stems.
| Device ID | K002996 |
| 510k Number | K002996 |
| Device Name: | SYNERGY HA COATED POROUS FEMORAL STEMS |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | David Henley |
| Correspondent | David Henley SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-25 |
| Decision Date | 2000-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556153642 | K002996 | 000 |
| 03596010459701 | K002996 | 000 |
| 03596010459695 | K002996 | 000 |
| 03596010459688 | K002996 | 000 |
| 03596010459671 | K002996 | 000 |
| 03596010459664 | K002996 | 000 |
| 03596010459657 | K002996 | 000 |
| 03596010459640 | K002996 | 000 |
| 03596010459831 | K002996 | 000 |
| 03596010459817 | K002996 | 000 |
| 03596010459794 | K002996 | 000 |
| 03596010459787 | K002996 | 000 |
| 03596010459756 | K002996 | 000 |
| 03596010459718 | K002996 | 000 |
| 03596010459725 | K002996 | 000 |
| 03596010459732 | K002996 | 000 |
| 00885556153635 | K002996 | 000 |
| 00885556054758 | K002996 | 000 |
| 00885556054116 | K002996 | 000 |
| 00885556048931 | K002996 | 000 |
| 00885556048542 | K002996 | 000 |
| 00885556047828 | K002996 | 000 |
| 00885556047675 | K002996 | 000 |
| 00885556018729 | K002996 | 000 |
| 03596010459824 | K002996 | 000 |
| 03596010459800 | K002996 | 000 |
| 03596010459770 | K002996 | 000 |
| 03596010459763 | K002996 | 000 |
| 03596010459749 | K002996 | 000 |