The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Restoration Monolithic Ii Hip Stem Series.
| Device ID | K944836 |
| 510k Number | K944836 |
| Device Name: | OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Terry Jarosz |
| Correspondent | Terry Jarosz 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-30 |
| Decision Date | 1995-04-10 |