Cleared Traditional

K213208 - Twist Drills
(FDA 510(k) Clearance)

K213208 · Biomet Microfixation · Neurology
Dec 2021
Decision
85d
Days
Class 2
Risk

K213208 is an FDA 510(k) clearance for the Twist Drills, 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 December 23, 2021, 85 days after receiving the submission on September 29, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K213208 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2021
Decision Date December 23, 2021
Days to Decision 85 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBE — Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4310

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