K883665 is an FDA 510(k) clearance for the COONRAD III TOTAL ELBOW. 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 February 3, 1989, 161 days after receiving the submission on August 26, 1988.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3150.
| 510(k) Number | K883665 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | August 26, 1988 |
| Decision Date | February 03, 1989 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | JDC — Prosthesis, Elbow, Constrained, Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3150 |