K062383 is an FDA 510(k) clearance for the UNISYN HA PLASMA MODULAR HIP. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented (Class II - Special Controls, product code LWJ).
Submitted by Hayes Medical, Inc. (El Dorado Hills, US). The FDA issued a Cleared decision on December 21, 2006, 128 days after receiving the submission on August 15, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K062383 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 2006 |
| Decision Date | December 21, 2006 |
| Days to Decision | 128 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LWJ — Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3360 |