The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Restoration Ha Hip Stems.
| Device ID | K983870 |
| 510k Number | K983870 |
| Device Name: | OSTEONICS RESTORATION HA HIP STEMS |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Kate Sutton |
| Correspondent | Kate Sutton OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-02 |
| Decision Date | 1998-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327019148 | K983870 | 000 |
| 07613327019025 | K983870 | 000 |
| 07613327019032 | K983870 | 000 |
| 07613327019049 | K983870 | 000 |
| 07613327019056 | K983870 | 000 |
| 07613327019063 | K983870 | 000 |
| 07613327019070 | K983870 | 000 |
| 07613327019087 | K983870 | 000 |
| 07613327019094 | K983870 | 000 |
| 07613327019100 | K983870 | 000 |
| 07613327019117 | K983870 | 000 |
| 07613327019124 | K983870 | 000 |
| 07613327019131 | K983870 | 000 |
| 07613327019018 | K983870 | 000 |