Cleared Traditional

MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT

K130682 · Hager& Meisinger GmbH · Dental
Aug 2013
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K130682 is an FDA 510(k) clearance for the MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT, 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 August 13, 2013, 153 days after receiving the submission on March 13, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.4880.

Submission Details

510(k) Number K130682 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2013
Decision Date August 13, 2013
Days to Decision 153 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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