Cleared Traditional

K213072 - 2.1 x 255mm Drill, 22mm Stop (FDA 510(k) Clearance)

K213072 · Biomet Micofixation · Neurology device

Aug 2022

Decision

334d

Days

Class 2

Risk

K213072 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 Micofixation (Jacksonville, US). The FDA issued a Cleared decision on August 23, 2022, 334 days after receiving the submission on September 23, 2021.

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

Submission Details

510(k) Number	K213072 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 23, 2021
Decision Date	August 23, 2022
Days to Decision	334 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF