The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Journey Unicondylar Femoral Implant.
| Device ID | K073175 |
| 510k Number | K073175 |
| Device Name: | JOURNEY UNICONDYLAR FEMORAL IMPLANT |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Contact | Marlon Ridley |
| Correspondent | Marlon Ridley SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-13 |
| Decision Date | 2007-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010627575 | K073175 | 000 |
| 03596010627322 | K073175 | 000 |
| 03596010629777 | K073175 | 000 |
| 03596010627438 | K073175 | 000 |
| 03596010627421 | K073175 | 000 |
| 03596010627407 | K073175 | 000 |
| 03596010627391 | K073175 | 000 |
| 03596010627384 | K073175 | 000 |
| 03596010627377 | K073175 | 000 |
| 03596010627360 | K073175 | 000 |
| 03596010627346 | K073175 | 000 |
| 03596010627339 | K073175 | 000 |
| 03596010627315 | K073175 | 000 |
| 03596010627414 | K073175 | 000 |
| 03596010627445 | K073175 | 000 |
| 03596010627568 | K073175 | 000 |
| 03596010627551 | K073175 | 000 |
| 03596010627544 | K073175 | 000 |
| 03596010627537 | K073175 | 000 |
| 03596010627520 | K073175 | 000 |
| 03596010627513 | K073175 | 000 |
| 03596010627506 | K073175 | 000 |
| 03596010627490 | K073175 | 000 |
| 03596010627483 | K073175 | 000 |
| 03596010627476 | K073175 | 000 |
| 03596010627469 | K073175 | 000 |
| 03596010627452 | K073175 | 000 |
| 03596010627308 | K073175 | 000 |