Cleared Special

K223199 - 2.1 x 255mm Drill, 22mm Stop (FDA 510(k) Clearance)

K223199 · Biomet Microfixation · Neurology device

Nov 2022

Decision

33d

Days

Class 2

Risk

K223199 is an FDA 510(k) clearance for the 2.1 x 255mm Drill, 22mm Stop. This device is classified as a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II - Special Controls, product code HBE).

Submitted by Biomet Microfixation (Jacksonville, US). The FDA issued a Cleared decision on November 15, 2022, 33 days after receiving the submission on October 13, 2022.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number	K223199 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 13, 2022
Decision Date	November 15, 2022
Days to Decision	33 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF