The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Series 7000 Basic Femoral Components.
| Device ID | K941128 |
| 510k Number | K941128 |
| Device Name: | OSTEONICS SERIES 7000 BASIC FEMORAL COMPONENTS |
| Classification | Exerciser, Powered |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Robert A Koch, J.d |
| Correspondent | Robert A Koch, J.d OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-09 |
| Decision Date | 1994-12-08 |