510(k) K062040— SBI TRIHEDRON MTP HEMI GT

Substantially Equivalent

Small Bone Innovations, Inc.

Clearance details

Applicant: Small Bone Innovations, Inc.
Product code: Code KWD
Advisory panel: Orthopedic
Date received: 2006-07-19
Decision date: 2006-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Adverse events under product code KWD

product code KWD

Injury: 164
Total: 164

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.