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510(k) Data Aggregation
K Number
K122415Device Name
X-FIX DYNAMIC EXTERNAL DISTRACTOR
Manufacturer
AREX USA LLC
Date Cleared
2013-03-15
(219 days)
Product Code
HTY, CLA
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
AREX USA LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The X-FIX is an external fixation system intended for use in the treatment of complex fracture dislocations, stable and unstable dislocations, fracture luxations, and pilon fractures in the PIP joint.
Device Description
The AREX USA X-FIX is a single use, lightweight, low profile external fixation system designed to treat fractures dislocations of the digits of the hand. The device is designed to help restore proper digit alignment and range of motion while permitting mobilization and normal anatomical movement.
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