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510(k) Data Aggregation
K Number
K101338Device Name
NEWFIX EXTERNAL FIXATION SYSTEM
Manufacturer
Date Cleared
2011-03-14
(306 days)
Product Code
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
TECHNOLOGIA Y DISENO INDUSTRIAL, S.A DE C.V
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Newfix® External Fixation System, consisting of axial fixators and frame components, is indicated for stabilization of open and/or unstable fractures where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting. NEWFIX® External Fixation System is intended for the fixation and for temporary or extended stabilization in cases such as: open fractures, closed fractures, poly-trauma fractures, supplement in the stabilization of minimal fixations in intra and extra articular fractures.
Device Description
The Newfix External Fixation System is a modular system that consists of various components including clamps, distractors, pins, carbon fiber rod, and stainless steel tubes for use in orthopedic and trauma treatment. The system is a modular design to provide options in frame construction, simplicity in frame components, and ease of use. The system is comprised of aluminum and stainless steel clamps (rod-to-rod and pin-to-rod), stainless steel fixation pins and stainless steel and carbon fiber connector rods. Pins include smooth and self drilling/self-tapping type threaded pin with diamond tip and cutting edges. The Newfix® External Fixation System is supplied non sterile and is intended for single patient use. None of the components of the Newfix System are reusable. The Newfix® External Fixation System includes instruments and accessory devices necessary for its use.
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