K153398 is an FDA 510(k) clearance for the Comprehensive SRS/Nexel Elbow. This device is classified as a Prosthesis, Elbow, Constrained, Cemented (Class II - Special Controls, product code JDC).
Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on February 3, 2016, 71 days after receiving the submission on November 24, 2015.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3150.
| 510(k) Number | K153398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2015 |
| Decision Date | February 03, 2016 |
| Days to Decision | 71 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 |