Cleared Traditional

The Micro Screw System, Micro Screw System Basic

K201210 · Hager& Meisinger GmbH · Dental
Oct 2021
Decision
521d
Days
Class 2
Risk

About This 510(k) Submission

K201210 is an FDA 510(k) clearance for the The Micro Screw System, Micro Screw System Basic, a Screw, Fixation, Intraosseous (Class II — Special Controls, product code DZL), submitted by Hager& Meisinger GmbH (Neuss, DE). The FDA issued a Cleared decision on October 8, 2021, 521 days after receiving the submission on May 5, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.4880.

Submission Details

510(k) Number K201210 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2020
Decision Date October 08, 2021
Days to Decision 521 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZL — Screw, Fixation, Intraosseous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4880

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