The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Unicondylar Femoral Component.
| Device ID | K030301 |
| 510k Number | K030301 |
| Device Name: | UNICONDYLAR FEMORAL COMPONENT |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| 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 | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-29 |
| Decision Date | 2003-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010483782 | K030301 | 000 |
| 03596010483775 | K030301 | 000 |
| 03596010483768 | K030301 | 000 |
| 03596010483751 | K030301 | 000 |
| 03596010483744 | K030301 | 000 |
| 03596010483737 | K030301 | 000 |