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510(k) Data Aggregation
K Number
K140675Device Name
EMERGE EXTERNAL FIXATION SYSTEM
Manufacturer
EMERGE MEDICAL, INC.
Date Cleared
2014-06-10
(84 days)
Product Code
KTT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
EMERGE MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Emerge External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
The system can be used for:
Stabilization of soft tissues and fractures
Polytrauma/multiple orthopedic trauma
Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures
Arthrodeses and osteotomies with soft tissue problems; failures of total joints
Neutralization of fractures stabilized with limited internal fixation
Non-unions/septic non-unions
Intra-operative reductions/stabilization tool to assist with indirect reduction
Unilateral rectilinear bone segment transport or leg lengthening
Device Description
The Emerge External Fixation System consists of combination clamp, rod-to-rod clamp, rods, pins, Schanz screws and associated instruments for site preparation and implant insertion. All components intended to be attached to bone are fabricated from medical grade stainless steel (3) 6L Stainless Steel per ASTM F138). External clamps are fabricated from Titanium Alloy (Ti-6Al-4V-ELI per ASTM F136), and radiolucent external fixation rods are fabricated from carbon fiber. The Emerge External Fixation System is provided non-sterile.
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