R-X-FIX EXTERNAL FIXATOR— 510(k) K051017

Substantially Equivalent

R-X-Fix

FDA 510(k) clearance K051017 for R-X-FIX EXTERNAL FIXATOR, Substantially Equivalent on 2005-06-29. Applicant: R-X-Fix.

Clearance details

Applicant: R-X-Fix
Product code: Code KTT
Advisory panel: Orthopedic
Date received: 2005-04-21
Decision date: 2005-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Round Rock, TX, US

Download summary PDF View on FDA.gov ↗

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.