SBI HAND FIXATION SYSTEM (TM)— 510(k) K050462

Substantially Equivalent

Small Bone Innovations, LLC

FDA 510(k) clearance K050462 for SBI HAND FIXATION SYSTEM (TM), Substantially Equivalent on 2005-04-26. Applicant: Small Bone Innovations, LLC.

Clearance details

Applicant: Small Bone Innovations, LLC
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2005-02-23
Decision date: 2005-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.