The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Insight Knee Positioning & Alignment System.
| Device ID | K953961 |
| 510k Number | K953961 |
| Device Name: | OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM |
| Classification | Table, Operating-room, Pneumatic |
| 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 | FWW |
| Subsequent Product Code | HWT |
| Subsequent Product Code | KKX |
| Subsequent Product Code | LXH |
| CFR Regulation Number | 878.4960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-22 |
| Decision Date | 1995-11-29 |