The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Super Secur-fit Ha Hip Stems And Super Secur-fit Plus Ha Hip Stems.
| Device ID | K020615 |
| 510k Number | K020615 |
| Device Name: | SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS |
| 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 | William J Cymbaluk |
| Correspondent | William J Cymbaluk HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH 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 | 2002-02-25 |
| Decision Date | 2002-05-13 |
| Summary: | summary |