K003131

Substantially Equivalent

MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT

Applicant: Biomet, Inc.
Product code: JDW
Advisory panel: Orthopedic
Date received: 2000-10-06
Decision date: 2000-11-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Adverse events under product code JDW

product code JDW

Injury: 717
Total: 717

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.