The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Omnifit Ii Hip Prostheses: Cement Fixation.
| Device ID | K870235 |
| 510k Number | K870235 |
| Device Name: | OMNIFIT II HIP PROSTHESES: CEMENT FIXATION |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-21 |
| Decision Date | 1987-05-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327012750 | K870235 | 000 |
| 07613327012668 | K870235 | 000 |
| 07613327012675 | K870235 | 000 |
| 07613327012682 | K870235 | 000 |
| 07613327012699 | K870235 | 000 |
| 07613327012705 | K870235 | 000 |
| 07613327012712 | K870235 | 000 |
| 07613327012729 | K870235 | 000 |
| 07613327012736 | K870235 | 000 |
| 07613327012743 | K870235 | 000 |
| 07613327012644 | K870235 | 000 |