K961304 is an FDA 510(k) clearance for the AURA HIP SYSTEM CEMENTED FEMORAL STEM/CEMENTED LONG FEMORAL STEM. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II - Special Controls, product code JDI).
Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on October 1, 1996, 180 days after receiving the submission on April 4, 1996.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3350.
| 510(k) Number | K961304 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 1996 |
| Decision Date | October 01, 1996 |
| Days to Decision | 180 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDI — Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3350 |