MAESTRO WRIST FRACTURE IMPLANT— 510(k) K080426

Substantially Equivalent

Biomet Manufacturing Corp

FDA 510(k) clearance K080426 for MAESTRO WRIST FRACTURE IMPLANT, Substantially Equivalent on 2008-07-29. Applicant: Biomet Manufacturing Corp.

Clearance details

Applicant: Biomet Manufacturing Corp
Product code: Code JWJ
Advisory panel: Orthopedic
Date received: 2008-02-20
Decision date: 2008-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JWJ

product code JWJ

Injury: 181
Total: 181

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.