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 | K910083 |
| 510k Number | K910083 |
| Device Name: | OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Pat Kramer |
| Correspondent | Pat Kramer OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-08 |
| Decision Date | 1991-04-01 |