The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Series 7000 Total Knee Femoral Components.
| Device ID | K944285 |
| 510k Number | K944285 |
| Device Name: | OSTEONICS SERIES 7000 TOTAL KNEE FEMORAL COMPONENTS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Terry Jarosz |
| Correspondent | Terry Jarosz OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-02 |
| Decision Date | 1994-12-19 |