K983452 is an FDA 510(k) clearance for the NELSON RESURFACING HEAD. This device is classified as a Prosthesis, Hip, Femoral, Resurfacing (Class II - Special Controls, product code KXA).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 3, 1998, 64 days after receiving the submission on September 30, 1998.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3400.
| 510(k) Number | K983452 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 1998 |
| Decision Date | December 03, 1998 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KXA — Prosthesis, Hip, Femoral, Resurfacing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3400 |