K962002 is an FDA 510(k) clearance for the AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM. This device is classified as a Prosthesis, Hip, Femoral Component, Cemented, Metal (Class II - Special Controls, product code JDG).
Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on August 8, 1996, 78 days after receiving the submission on May 22, 1996.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K962002 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 1996 |
| Decision Date | August 08, 1996 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDG — Prosthesis, Hip, Femoral Component, Cemented, Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3360 |