The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Omnifit Epf Dual Geometry Acetabular Cup.
| Device ID | K912654 |
| 510k Number | K912654 |
| Device Name: | OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| 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 | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-17 |
| Decision Date | 1991-08-16 |