K053189 is an FDA 510(k) clearance for the COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES. This device is classified as a Prosthesis, Elbow, Constrained, Cemented (Class II - Special Controls, product code JDC).
Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 9, 2005, 24 days after receiving the submission on November 15, 2005.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3150.
| 510(k) Number | K053189 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2005 |
| Decision Date | December 09, 2005 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDC — Prosthesis, Elbow, Constrained, Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3150 |