K053536 is an FDA 510(k) clearance for the DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS. This device is classified as a Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (Class III - Premarket Approval, product code KWA).
Submitted by Zimmer GmbH (Warsaw, US). The FDA issued a Cleared decision on March 16, 2006, 87 days after receiving the submission on December 19, 2005.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3330.
| 510(k) Number | K053536 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2005 |
| Decision Date | March 16, 2006 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWA — Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 888.3330 |