SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061— 510(k) K092754

Substantially Equivalent

Small Bone Innovations, Inc.

FDA 510(k) clearance K092754 for SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061, Substantially Equivalent on 2010-01-19. Applicant: Small Bone Innovations, Inc..

Clearance details

Applicant: Small Bone Innovations, Inc.
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2009-09-09
Decision date: 2010-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morrisville, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.