The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Ps Head And Neck Hip Stem Series.
| Device ID | K902712 |
| 510k Number | K902712 |
| Device Name: | OSTEONICS PS HEAD AND NECK HIP STEM SERIES |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| 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 | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-20 |
| Decision Date | 1990-08-09 |