The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Omnifit Threaded Acetabular Components 2005 Series.
| Device ID | K851404 |
| 510k Number | K851404 |
| Device Name: | OMNIFIT THREADED ACETABULAR COMPONENTS 2005 SERIES |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Dennis H Crane |
| Correspondent | Dennis H Crane OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | KWA |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-09 |
| Decision Date | 1985-06-18 |