K925536 is an FDA 510(k) clearance for the HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM. This device is classified as a Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (Class II - Special Controls, product code KWY).
Submitted by Orthomet, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 7, 1994, 431 days after receiving the submission on November 2, 1992.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3390.
| 510(k) Number | K925536 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | November 02, 1992 |
| Decision Date | January 07, 1994 |
| Days to Decision | 431 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3390 |