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510(k) Data Aggregation
K Number
K012320Device Name
POWERPRO BATTERY SYSTEM
Manufacturer
LINVATEC CORP.
Date Cleared
2001-10-19
(88 days)
Product Code
HAB, FRG, GEY, HBC
Regulation Number
878.4820Why did this record match?
Product Code :
HAB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PowerPro™ Battery System functions as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone. The fields of application include orthopedic procedures such as osteotomies, small and large bone trauma, orthopedic reconstruction, and total joint replacement, neurosurgical fusion and plating procedures, and medial sternotomy.
The PowerPro Battery System also includes a sterilization case to enclose the rechargeable batteries during sterilization, and also to maintain sterility of the batteries until used.
Device Description
The PowerPro Battery System is a powered instrument system consisting of various pistol-grip handpieces, universal battery charger, rechargeable batteries and sterilization trays. The handpieces utilize various attachments, such as blades, burs, drills and routers.
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