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510(k) Data Aggregation
K Number
K133104Device Name
VAN HIP FRACTURE SYSTEM
Manufacturer
Date Cleared
2014-03-10
(161 days)
Product Code
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
EPIX ORTHOPAEDIC, CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The VAN Hip Fracture System is indicated for fixation of fractures of the femur, including intertrochanteric fractures, pertrochanteric fractures, subtrochanteric fractures and combinations of these fractures, pathological fractures in both diaphyseal and trochanteric areas, and nonunion or malunion.
Device Description
The VAN Hip Fracture System includes short and long intramedullary nails, lag screws and distal locking cortical bone screws. The nail contains an angle adjust feature that allows for the neck/shaft angle to be adjusted to accommodate anatomical variations in the femoral neck angle.
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