K972691 is an FDA 510(k) clearance for the ABC TOTAL ELBOW PROTHESIS. This device is classified as a Prosthesis, Elbow, Semi-constrained, Cemented (Class II - Special Controls, product code JDB).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 15, 1997, 90 days after receiving the submission on July 17, 1997.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3160.
| 510(k) Number | K972691 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 17, 1997 |
| Decision Date | October 15, 1997 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDB — Prosthesis, Elbow, Semi-constrained, Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3160 |