21 CFR 882.4310 — Drills, Burrs, Trephines & Accessories (Simple, Powered)

Neurology (NE) · Part 882 Subpart E—Neurological Surgical Devices · § 882.4310

Identification

Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)2653rd Party
NLNDrills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed213rd Party
PPTCranial Surgical Planning And Instrument Guides24SaMD
Innolitics

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