The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Modification To Journey Unicondylar Femoral Implant.
| Device ID | K081351 |
| 510k Number | K081351 |
| Device Name: | MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | SMITH & NEPHEW, INC. 1450 E BROOKS ROAD Memphis, TN 38116 |
| Contact | Nicholas B Tabrizi |
| Correspondent | Nicholas B Tabrizi SMITH & NEPHEW, INC. 1450 E BROOKS ROAD Memphis, TN 38116 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-14 |
| Decision Date | 2008-07-24 |
| Summary: | summary |