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510(k) Data Aggregation
K Number
K112663Device Name
ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL
Manufacturer
Date Cleared
2012-03-12
(181 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
ENHATCH ORTHOPAEDICS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EnHatch Orthopaedics Patient Optimized Humeral Fracture System is indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal Humerus, particularly in osteopenic bone.
Device Description
The EnHatch Orthopaedics Patient Optimized Humeral Fracture System is a system of pre-contoured fracture plates, screws, and instrumentation for the repair of fractures of the proximal Humerus. The plates are designed to fit the natural anatomy of the proximal Humerus and include 3 sizes, different components for left and right Humeri, and plates designed to fit in different positions on the humerus. The proximal portions of the plates accept 3.5 mm locking screws for fixation of head, tuberosity, and shaft fragments to the plate. The distal portions of the plates accept 3.5 mm cortex compression screws which hold the plate construct to the humeral shaft.
EnHatch Orthopaedics Patient Optimized Humeral Fracture System Plates and Screws will be sold non-sterile. They are packaged and shipped in comprehensive trays that allow for secure transportation and on site sterilization. Products used for replenishment will be shipped, non-sterile, in a protective package (poly bag or tube).
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