K032964 is an FDA 510(k) clearance for the EXACTECH 12/14 ALUMINA FEMORAL HEAD. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II - Special Controls, product code LPH).
Submitted by Exactech, Inc. (Gainesville, US). The FDA issued a Cleared decision on November 13, 2003, 51 days after receiving the submission on September 23, 2003.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3358.
| 510(k) Number | K032964 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2003 |
| Decision Date | November 13, 2003 |
| Days to Decision | 51 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3358 |