The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Restoration Monolithic Hip Stem.
| Device ID | K943774 |
| 510k Number | K943774 |
| Device Name: | OSTEONICS RESTORATION MONOLITHIC HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Robert A Koch, J.d. |
| Correspondent | Robert A Koch, J.d. OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-02 |
| Decision Date | 1995-03-06 |