21 CFR 882.4300 — Drills, Burrs, Trephines & Accessories (Manual)

Neurology (NE) · Part 882 Subpart E—Neurological Surgical Devices · § 882.4300

Identification

Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
HBGDrills, Burrs, Trephines & Accessories (Manual)2173rd Party
NLODrills, Burrs, Trephines And Accessories (Manual), Reprocessed203rd Party
Innolitics

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