The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Omnifit Ha Hip Stem Series, Osteonics Secur-fit Ha Hip Stem Series, Osteonics Primary Secur-fit Plus Hip Stems.
| Device ID | K982032 |
| 510k Number | K982032 |
| Device Name: | OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS 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 (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-10 |
| Decision Date | 1998-07-09 |
| Summary: | summary |