21 CFR 882.4305 — Drills, Burrs, Trephines & Accessories (Compound, Powered)

Neurology (NE) · Part 882 Subpart E—Neurological Surgical Devices · § 882.4305

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.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)2183rd Party
NLPDrills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed203rd Party
Innolitics

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