Cleared Traditional

K121624 - BIOMET MICROFIXATION NEURO PLATING SYSTEM
(FDA 510(k) Clearance)

K121624 · Biomet Microfixation · Neurology
Oct 2012
Decision
133d
Days
Class 2
Risk

K121624 is an FDA 510(k) clearance for the BIOMET MICROFIXATION NEURO PLATING SYSTEM. This device is classified as a Plate, Cranioplasty, Preformed, Alterable (Class II — Special Controls, product code GWO).

Submitted by Biomet Microfixation (Jacksonville, US). The FDA issued a Cleared decision on October 12, 2012, 133 days after receiving the submission on June 1, 2012.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5320.

Submission Details

510(k) Number K121624 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2012
Decision Date October 12, 2012
Days to Decision 133 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWO — Plate, Cranioplasty, Preformed, Alterable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5320

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