The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Microsutered Femoral Componentes.
| Device ID | K926201 |
| 510k Number | K926201 |
| Device Name: | OSTEONICS MICROSUTERED FEMORAL COMPONENTES |
| Classification | System, Delivery, Allergen And Vaccine |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Robert A Koch |
| Correspondent | Robert A Koch OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | LDH |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-09 |
| Decision Date | 1993-06-22 |