The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Hip Revision Wedges.
| Device ID | K905406 |
| 510k Number | K905406 |
| Device Name: | OSTEONICS HIP REVISION WEDGES |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Pat Kramer |
| Correspondent | Pat Kramer 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 | 1990-12-03 |
| Decision Date | 1991-01-04 |