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510(k) Data Aggregation
K Number
K971272Device Name
TRAUMA-FIX EXTERNAL FIXATOR
Manufacturer
TREND MEDICAL, INC.
Date Cleared
1997-06-05
(62 days)
Product Code
KTW, CLA
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
TREND MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. External fixation of long bone fractures.
2. External fixation and stabilization of surgical osteotomy sites.
3. Leg lengthening procedures.
4. Knee, hip and ankle arthrodesis.
5. External fixation of septic and aseptic non-union of long bones
6. Pelvic fixation
Device Description
The Trauma-Fix® External Fixator is offered as both a unilateral (uni-bar) and quadrilateral style (also called multi-plane) external fixation frame. External fixators known as unibar and multi-plane are typical of present industry standard designs. The uni-bar fixator concept is an outgrowth of the multi-plane fixator varying chiefly in the use of half-pins rather than the transfixing pins typical of multi-plane fixation, though occasionally half-pins are used with multi-plane fixators.
The Trauma-Fix® External Fixator line is made up of the following items: Fixator Pin Holder Clamps, 5 & 8 mm diameter Articulation Coupling, 5 & 8 mm diameter Connecting Rods, 5 & 8 mm diameter Adjustable Telescopic Connecting Rods, 5 & 8 mm diameter Small Lengthining Device for Forearm Colles Forearm Frame Half-Pins Full-Pins/Transfixing Pins KTB Wires Uni-Bar Pin Clamp Uni-Bar Smooth Rods Uni-Bar Compression & Distraction Rod Uni-Bar Connector Instruments Drill Brace Chuck, 3, 4, 5, 6, mm T-Wrench Open Wrench Hex Screw Driver Drill Bit Trochar & Sleeve
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