K983036 is an FDA 510(k) clearance for the SINGLE AXLE TOTAL ELBOW. This device is classified as a Prosthesis, Elbow, Constrained, Cemented (Class II - Special Controls, product code JDC).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 30, 1999, 242 days after receiving the submission on August 31, 1998.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3150.
| 510(k) Number | K983036 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 1998 |
| Decision Date | April 30, 1999 |
| Days to Decision | 242 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 |