CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231

• K Number: K073336
• Device Name: CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231
• Manufacturer: Codman & Shurtleff, Inc.
• Date Cleared: 2008-01-04 ( 37 days)
• Product Code: HBF
• Regulation Number: 882.4305
• Type: Special
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories.

(a)
Identification. Powered compound cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments employ a clutch mechanism to disengage the tip of the instrument after penetrating the skull to prevent plunging of the tip into the brain.(b)
Classification. Class II (performance standards).