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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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K Number
K094043Device Name
LIGAMENTOTAXOR
Manufacturer
AREX USA
Date Cleared
2010-08-17
(229 days)
Product Code
HTY
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
AREX USA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ligamentotaxor 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 Ligamentotaxor 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.
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K Number
K081011Device Name
AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45
Manufacturer
AREX USA
Date Cleared
2008-11-07
(212 days)
Product Code
HWC, PIN
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
AREX USA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AREX SCRU2 headless compression screw is intended for fixation of intra-articular and extra-articular fractures of the upper and lower extremities, as well as non-unions of small bones and bone fragments, arthrodesis of small joints, bunionectomies and osteotomies. Examples include scaphoid and other carpal bones, metacarpais, tarsals, metatarsals, patella, ulmar styloid, capitellum, radial head and radial styloid.
Device Description
The AREX SCRU 2 Headless Compression Screws are cannulated, self drilling, self tapping, dual-pitch threaded devices which can be countersunk into the bone. The screw is available in titanium alloy with and OD of 2 5 or 3 mm and lengths from 10mm up to 45 mm, in increments of 5 mm. The screws are supplied non-sterile.
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