The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Synergy Cemented Hip Stem.
| Device ID | K990369 |
| 510k Number | K990369 |
| Device Name: | SYNERGY CEMENTED HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Neal Defibaugh |
| Correspondent | Neal Defibaugh SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-08 |
| Decision Date | 1999-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010443120 | K990369 | 000 |
| 03596010410498 | K990369 | 000 |
| 03596010410504 | K990369 | 000 |
| 03596010410511 | K990369 | 000 |
| 03596010410528 | K990369 | 000 |
| 03596010410535 | K990369 | 000 |
| 03596010410542 | K990369 | 000 |
| 03596010410559 | K990369 | 000 |
| 03596010410566 | K990369 | 000 |
| 03596010410573 | K990369 | 000 |
| 03596010410580 | K990369 | 000 |
| 03596010410597 | K990369 | 000 |
| 03596010410603 | K990369 | 000 |
| 03596010410610 | K990369 | 000 |
| 03596010442352 | K990369 | 000 |
| 03596010442369 | K990369 | 000 |
| 03596010443113 | K990369 | 000 |
| 03596010410481 | K990369 | 000 |