ABC TOTAL ELBOW PROTHESIS— 510(k) K972691

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K972691 for ABC TOTAL ELBOW PROTHESIS, Substantially Equivalent on 1997-10-15. Applicant: Biomet, Inc..

Clearance details

Applicant: Biomet, Inc.
Product code: Code JDB
Advisory panel: Orthopedic
Date received: 1997-07-17
Decision date: 1997-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code JDB

product code JDB

Injury: 352
Total: 352

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.