The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Omnifit Total Knee Bone Augmentation Wedges.
| Device ID | K874635 |
| 510k Number | K874635 |
| Device Name: | OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Dennis H Crane |
| Correspondent | Dennis H Crane OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-10 |
| Decision Date | 1988-03-10 |