K930771 is an FDA 510(k) clearance for the PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II - Special Controls, product code JDI).
Submitted by Orthomet, Inc. (Minneapolis, US). The FDA issued a Cleared decision on November 30, 1994, 652 days after receiving the submission on February 16, 1993.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3350.
| 510(k) Number | K930771 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | February 16, 1993 |
| Decision Date | November 30, 1994 |
| Days to Decision | 652 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | JDI — Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3350 |