Gexfix External Fixation— 510(k) K160972

Name: FDA 510(k) clearance K160972
Creator: U.S. Food and Drug Administration
Published: 2016-12-28

Substantially Equivalent

Gexfix International Corp.

FDA 510(k) clearance K160972 for Gexfix External Fixation, Substantially Equivalent on 2016-12-28. Applicant: Gexfix International Corp.. Device class: 2.

Clearance details

Applicant: Gexfix International Corp.
Product code: Code KTT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2016-04-06
Decision date: 2016-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

Download summary PDF View on FDA.gov ↗

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K253202 — Hoffmann LRF System2025-12-19

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.