K181307 is an FDA 510(k) clearance for the Zimmer Nexel Total Elbow, Connrad/Morrey 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 January 28, 2019, 256 days after receiving the submission on May 17, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3150.
| 510(k) Number | K181307 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 2018 |
| Decision Date | January 28, 2019 |
| Days to Decision | 256 days |
| Submission Type | Traditional |
| 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 |