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510(k) Data Aggregation
K Number
K112599Device Name
INSURGICAL SINGLE USE POWER EQUIPMENT
Manufacturer
INSURGICAL LLC
Date Cleared
2012-11-06
(426 days)
Product Code
KIJ
Regulation Number
878.4820Why did this record match?
Applicant Name (Manufacturer) :
INSURGICAL LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Insurgical™ Single Use Power Equipment is intended for use in the cutting, drilling, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices. It can also be used to cut metal.
Device Description
The Insurgical™ Single Use Power Equipment System includes surgical power tools and rechargeable batteries. The battery powered DC Motor products include the Insurgical Drill, and the Insurgical Orthopedic Reamer. Insurgical handpieces and attachments are provided pre-sterilized and ready to use. The powered DC Motor products and attachments are single-use and intended to be disposed of after use. The batteries can be recharged and are re-usable. The Insurgical Drill is designed for drilling holes and placing bone screws in a variety of reconstructive and trauma procedures. The Insurgical Orthopedic Reamer can be used for boring, drilling, and reaming during orthopedic procedures.
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