The following data is part of a premarket notification filed by Valpo Orthopedic Technology, Inc. with the FDA for Unicompartmental Knee.
| Device ID | K072704 |
| 510k Number | K072704 |
| Device Name: | UNICOMPARTMENTAL KNEE |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | VALPO ORTHOPEDIC TECHNOLOGY, INC. 438 E 200 N Warsaw, IN 46582 |
| Contact | Hans Stover |
| Correspondent | Hans Stover VALPO ORTHOPEDIC TECHNOLOGY, INC. 438 E 200 N Warsaw, IN 46582 |
| Product Code | HRY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-24 |
| Decision Date | 2008-02-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811767025553 | K072704 | 000 |
| 00811767025348 | K072704 | 000 |
| 00811767025331 | K072704 | 000 |
| 00811767025324 | K072704 | 000 |
| 00811767025317 | K072704 | 000 |
| 00811767025300 | K072704 | 000 |
| 00811767025294 | K072704 | 000 |
| 00811767025287 | K072704 | 000 |
| 00811767025270 | K072704 | 000 |
| 00811767025263 | K072704 | 000 |
| 00811767025256 | K072704 | 000 |
| 00811767025249 | K072704 | 000 |
| 00811767025355 | K072704 | 000 |
| 00811767025362 | K072704 | 000 |
| 00811767025379 | K072704 | 000 |
| 00811767025546 | K072704 | 000 |
| 00811767025539 | K072704 | 000 |
| 00811767025461 | K072704 | 000 |
| 00811767025454 | K072704 | 000 |
| 00811767025447 | K072704 | 000 |
| 00811767025430 | K072704 | 000 |
| 00811767025423 | K072704 | 000 |
| 00811767025416 | K072704 | 000 |
| 00811767025409 | K072704 | 000 |
| 00811767025393 | K072704 | 000 |
| 00811767025386 | K072704 | 000 |
| 00811767025232 | K072704 | 000 |