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510(k) Data Aggregation
Device Name
QuikFix External Fixator: Knee-Spanning PackManufacturer
Date Cleared
2026-03-23
(68 days)
Product Code
Regulation Number
888.3030Type
TraditionalPanel
OrthopedicAge Range
All
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The QuikFix External Fixator: Knee-Spanning Pack is indicated for treatment of long bone fractures of the leg that require external fixation. Specifically, the system is intended for:
- Temporary stabilization of open or closed acute fractures with lower limb soft tissue injuries;
- Temporary stabilization of lower limb fractures in the context of polytrauma;
- Temporary stabilization of lower limbs after removal of total joint (knee, and ankle) arthroplasty for infection or other failure;
- Temporary stabilization of lower limb non-unions;
- Intra-operative temporary stabilization tool of the lower limb to assist with indirect reduction.
QuikFix External Fixator: Knee-Spanning Pack is intended for use in a non-weight bearing patient.
QuikFix External Fixator: Knee-Spanning Pack components are for single use only and are suitable for use in an MR environment.
Device Description
QuikFix External Fixator: Knee-Spanning Pack includes various elements designed to build a fixator construct. The system includes fixation pins, clamps and rods.
AI/ML Overview
N/A
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