EXTERNAL FIXATION— 510(k) K052605

Substantially Equivalent

Gexfix USA, Inc.

FDA 510(k) clearance K052605 for EXTERNAL FIXATION, Substantially Equivalent on 2005-11-10. Applicant: Gexfix USA, Inc..

Clearance details

Applicant: Gexfix USA, Inc.
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2005-09-21
Decision date: 2005-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

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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.