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510(k) Data Aggregation
K Number
K023868Device Name
DAN KERRISON RONGEURS, MODELS K1 + BILLY 1Manufacturer
Date Cleared
2003-02-07
(79 days)
Product Code
Regulation Number
882.4840Type
TraditionalPanel
NeurologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
DANNORITZER MEDICAL INSTRUMENTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
DANNORITZER manual rongeurs are designed for cutting or biting bone during surgery involving the skull or spinal column.
Device Description
Not Found
AI/ML Overview
I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement. The document is a clearance letter from the FDA for a medical device (Dan Kerrison Rongeurs), stating that it is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance and marketing permissions but does not delve into specific performance studies or acceptance criteria.
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