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510(k) Data Aggregation
K Number
K080542Device Name
DISTRAX
Manufacturer
JOHN W. KING
Date Cleared
2008-12-15
(292 days)
Product Code
MQN
Regulation Number
872.4760Why did this record match?
Applicant Name (Manufacturer) :
JOHN W. KING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Distrax is intended for mandibular symphyseal widening and mandibular lengthening by distraction osteogenesis. Following the distraction osteogenesis, the Distrax may also be used for temporary stabilization during the consolidation phase. The Distrax is intended for single patient use only.
Device Description
Distrax™ is a preassembled distraction system consisting of the following major components: Distraction Screw, Distractor Arms, Fixed Screw, Threaded Tube, Locknut (optional). Titanium Bone Screws (K063298) and brackets (surgical stainless steel, 24 gauge) are required for use and should be obtained by the surgeon and orthodontist, respectively. An Activation Key is also supplied to turn the Distraction Screw. The patient contact materials of the Distrax are made of austenitic stainless steel type 304 (chromium-nickel stainless class) and type 316 (chromium-nickel class containing 2-3% molybdenum). These materials are specified in ISO standards 5832-1 and 5832-9 for medical implant applications. The device must be cleaned and sterilized before use.
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