The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Omnifit/omniflex/odc/omnifit-ha Hip Stem Series.
| Device ID | K913812 |
| 510k Number | K913812 |
| Device Name: | OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-26 |
| Decision Date | 1991-11-22 |