X-FIX DYNAMIC EXTERNAL DISTRACTOR— 510(k) K122415

Name: FDA 510(k) clearance K122415
Creator: U.S. Food and Drug Administration
Published: 2013-03-15

Substantially Equivalent

Arex USA, LLC

FDA 510(k) clearance K122415 for X-FIX DYNAMIC EXTERNAL DISTRACTOR, Substantially Equivalent on 2013-03-15. Applicant: Arex USA, LLC. Device class: 2.

Clearance details

Applicant: Arex USA, LLC
Product code: Code HTY
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2012-08-08
Decision date: 2013-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edgewater, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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.