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510(k) Data Aggregation
K Number
K972057Device Name
POWERTREK INSTRUMENTS
Manufacturer
Date Cleared
1997-11-05
(156 days)
Product Code
Regulation Number
874.4250Why did this record match?
Applicant Name (Manufacturer) :
MEDTREK CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PowerTREK Instrument is indicated for use in the removal of tissue or bone in minimally invasive ENT and ,Orthopedic procedures. It is to be used within a surgical setting under sterile technique.
Device Description
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