Cleared Traditional

Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems

K161318 · Tedan Surgical Innovations, LLC · Neurology
Mar 2017
Decision
313d
Days
Class 2
Risk

About This 510(k) Submission

K161318 is an FDA 510(k) clearance for the Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems, a Retractor, Self-retaining, For Neurosurgery (Class II — Special Controls, product code GZT), submitted by Tedan Surgical Innovations, LLC (Sugar Land, US). The FDA issued a Cleared decision on March 20, 2017, 313 days after receiving the submission on May 11, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4800.

Submission Details

510(k) Number K161318 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 2016
Decision Date March 20, 2017
Days to Decision 313 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

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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