K041170 is an FDA 510(k) clearance for the SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II - Special Controls, product code LZO).
Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on November 9, 2004, 189 days after receiving the submission on May 4, 2004.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3353.
| 510(k) Number | K041170 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2004 |
| Decision Date | November 09, 2004 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3353 |