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510(k) Data Aggregation
K Number
K091258Device Name
EXTRAFIX EXTERNAL FIXATION SYSTEM
Manufacturer
QFX TECHNOLOGIES, INC.
Date Cleared
2009-07-24
(86 days)
Product Code
KTT, JDW
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
QFX TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Extrafix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone ( foot, femur, and tibia) and pelvic fractures that require external fixation. Specifically, the system is intended for:
- Temporary stabilization of open or closed acute fractures with soft tissue injuries; .
- Definitive stabilization of open or closed fractures where open or alternative closed # treatment is undesirable or otherwise contraindicated;
- Stabilization of fractures in the context of polytrauma; .
- Temporary or definitive stabilization of certain pelvic fractures or pelvic ring injuries;
- Arthrodesis and osteotomies with associated soft tissue problems; .
- Stabilization of limbs after removal of total joint (knee, and ankle) arthroplasty for . infection or other failure;
- Neutralization of fractures stabilized with limited internal fixation; .
- Stabilization of non-unions; and
- Intraoperative temporary stabilization tool to assist with indirect reduction.
Device Description
The Extrafix External Fixation System includes various elements designed to build a fixator construct. The system includes clamps, posts, bars, and fixation pins.
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