Cleared Traditional

MEDICON Spinal Spreading Systems

K161680 · Medicon EG · Neurology
Mar 2017
Decision
280d
Days
Class 2
Risk

About This 510(k) Submission

K161680 is an FDA 510(k) clearance for the MEDICON Spinal Spreading Systems, a Retractor, Self-retaining, For Neurosurgery (Class II — Special Controls, product code GZT), submitted by Medicon EG (Tuttlingen, DE). The FDA issued a Cleared decision on March 24, 2017, 280 days after receiving the submission on June 17, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4800.

Submission Details

510(k) Number K161680 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2016
Decision Date March 24, 2017
Days to Decision 280 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GZT — Retractor, Self-retaining, For Neurosurgery
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4800

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