The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Omnifit Ad Hip Stem Series.
| Device ID | K940715 |
| 510k Number | K940715 |
| Device Name: | OSTEONICS OMNIFIT AD HIP STEM SERIES |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| 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 | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-18 |
| Decision Date | 1995-06-07 |