SBI TRIHEDRON MTP HEMI GT— 510(k) K062040

Name: FDA 510(k) clearance K062040
Creator: U.S. Food and Drug Administration
Published: 2006-10-03

Substantially Equivalent

Small Bone Innovations, Inc.

FDA 510(k) clearance K062040 for SBI TRIHEDRON MTP HEMI GT, Substantially Equivalent on 2006-10-03. Applicant: Small Bone Innovations, Inc.. Device class: 2.

Clearance details

Applicant: Small Bone Innovations, Inc.
Product code: Code KWD
Device class: Class 2
Regulation: 21 CFR 888.3730
Advisory panel: Orthopedic
Date received: 2006-07-19
Decision date: 2006-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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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.