The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Patello-femoral Implant.
| Device ID | K051086 |
| 510k Number | K051086 |
| Device Name: | SMITH & NEPHEW PATELLO-FEMORAL IMPLANT |
| Classification | Prosthesis, Knee, Patello/femoral, Semi-constrained, Cemented, Metal/polymer |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Gino Rouss |
| Correspondent | Gino Rouss SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | KRR |
| CFR Regulation Number | 888.3540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-28 |
| Decision Date | 2005-05-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010573315 | K051086 | 000 |
| 03596010573308 | K051086 | 000 |
| 03596010544247 | K051086 | 000 |
| 03596010544230 | K051086 | 000 |
| 03596010544223 | K051086 | 000 |
| 03596010544216 | K051086 | 000 |
| 03596010544209 | K051086 | 000 |
| 03596010544193 | K051086 | 000 |