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 | K951932 |
| 510k Number | K951932 |
| 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 (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-25 |
| Decision Date | 1995-09-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327019285 | K951932 | 000 |
| 07613327019162 | K951932 | 000 |
| 07613327019179 | K951932 | 000 |
| 07613327019186 | K951932 | 000 |
| 07613327019193 | K951932 | 000 |
| 07613327019209 | K951932 | 000 |
| 07613327019216 | K951932 | 000 |
| 07613327019223 | K951932 | 000 |
| 07613327019230 | K951932 | 000 |
| 07613327019247 | K951932 | 000 |
| 07613327019254 | K951932 | 000 |
| 07613327019261 | K951932 | 000 |
| 07613327019278 | K951932 | 000 |
| 07613327019155 | K951932 | 000 |