The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Synergy Hip System.
| Device ID | K061066 |
| 510k Number | K061066 |
| Device Name: | SYNERGY HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | John Reabe |
| Correspondent | John Reabe SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | LZO |
| Subsequent Product Code | FZP |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LPH |
| Subsequent Product Code | MEH |
| Subsequent Product Code | NEU |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-17 |
| Decision Date | 2006-07-14 |
| Summary: | summary |