K062408 is an FDA 510(k) clearance for the SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD. This device is classified as a Prosthesis, Hip, Hemi-, Femoral, Metal (Class II - Special Controls, product code KWL).
Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on September 12, 2006, 26 days after receiving the submission on August 17, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3360.
| 510(k) Number | K062408 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2006 |
| Decision Date | September 12, 2006 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWL — Prosthesis, Hip, Hemi-, Femoral, Metal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3360 |