The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Ion Implant Mod-ml Uniknee Femoral Comp.
| Device ID | K911373 |
| 510k Number | K911373 |
| Device Name: | OSTEONICS ION IMPLANT MOD-ML UNIKNEE FEMORAL COMP |
| Classification | Prosthesis, Knee, Femorotibial, Semi-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 | HRY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-28 |
| Decision Date | 1991-06-26 |