SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS)— 510(k) K190069

Name: FDA 510(k) clearance K190069
Creator: U.S. Food and Drug Administration
Published: 2019-05-14

Substantially Equivalent

Arrowhead De, LLC

FDA 510(k) clearance K190069 for SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS), Substantially Equivalent on 2019-05-14. Applicant: Arrowhead De, LLC. Device class: 2.

Clearance details

Applicant: Arrowhead De, LLC
Product code: Code KTT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2019-01-15
Decision date: 2019-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Collierville, TN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KTT

product code KTT

Death: 11
Injury: 3,097
Malfunction: 1,261
Total: 4,369

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.