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510(k) Data Aggregation
K Number
K231213Device Name
HKT Anatomical Locking Trauma System
Manufacturer
Date Cleared
2024-01-19
(266 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Hankil Tech Medical Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The HKT Anatomical Locking Trauma System is intended for adult patients for fixation of fractures, osteotomies, and non-unions of the clavicle, tibia, femur, fibula, radius, ulna, humerus and pelvis.
Device Description
The HKT Anatomical Locking Trauma System consists of metallic bone fixation plates and metallic screw fasteners. The bone plates and screws are composed of titanium alloy Ti-6Al-4V and commercially pure (Cp) titanium. The devices are used for fixation of fractures, osteotomies, and non-unions of the clavicle, tibia, femur, fibula, radius, ulna, humerus and pelvis. The bone plates are anatomically pre-contoured and offered in various shapes and sizes to allow for the orthopedic surgeon or equivalent medical professional to choose which device best fits each patient within the indication for use.
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