BIONX DISTAL RADIUS SCREW— 510(k) K974876

Substantially Equivalent

Bionx Implants, Inc.

FDA 510(k) clearance K974876 for BIONX DISTAL RADIUS SCREW, Substantially Equivalent on 1998-03-20. Applicant: Bionx Implants, Inc..

Clearance details

Applicant: Bionx Implants, Inc.
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 1997-12-29
Decision date: 1998-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

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.