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K Number
K983092
Device Name
TRITON HUDSON CHUCK ATTACHMENT
Manufacturer
MEDNEXT, INC.
Date Cleared
1998-11-06

(64 days)

Product Code
HBB
Regulation Number
882.4370
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For use during surgical procedures to cut hard tissue, bone and soft tissue and to hold cranial perforators that have a standard Hudson fitting.

Device Description

Hudson Chuck for Mednext TRITON Handpiece

AI/ML Overview

This request cannot be fulfilled. The document provided is a 510(k) clearance letter from the FDA, a statement of intended use, and the device name. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This type of information is typically found in the 510(k) submission itself or in published studies related to the device, neither of which are part of the provided text.

§ 882.4370 Pneumatic cranial drill motor.

(a)
Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).