K921139 is an FDA 510(k) clearance for the HEALEY REVISION COMPONENT SYSTEM. This device is classified as a Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) (Class III - Premarket Approval, product code JDL).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 1, 1992, 113 days after receiving the submission on March 10, 1992.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3320.
| 510(k) Number | K921139 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 1992 |
| Decision Date | July 01, 1992 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | JDL — Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 888.3320 |