The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Precision Osteolock Femoral Stems With Pure-fix Ha Coating.
| Device ID | K992025 |
| 510k Number | K992025 |
| Device Name: | PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Marybeth Naughton |
| Correspondent | Marybeth Naughton HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH 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 | 1999-06-16 |
| Decision Date | 1999-08-13 |
| Summary: | summary |