K982398 is an FDA 510(k) clearance for the BIOMET 100% POROUS COATED BIAXIAL 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 August 11, 1998, 32 days after receiving the submission on July 10, 1998.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3150.
| 510(k) Number | K982398 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 1998 |
| Decision Date | August 11, 1998 |
| Days to Decision | 32 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 |