The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Omniflex-c Uhmwpe Mid-shaft Restrictor.
| Device ID | K923616 |
| 510k Number | K923616 |
| Device Name: | OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR |
| Classification | Prosthesis, Hip, Cement Restrictor |
| 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 | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-21 |
| Decision Date | 1992-10-30 |