Cleared Traditional

K161680 - MEDICON Spinal Spreading Systems

K161680 is an FDA 510(k) clearance for MEDICON Spinal Spreading Systems, manufactured by Medicon EG. The device is a Class 2 Neurology device with product code GZT cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K161680 · Medicon EG · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
280d
Days
Class 2
Risk

K161680 is an FDA 510(k) clearance for the MEDICON Spinal Spreading Systems. Classified as Retractor, Self-retaining, For Neurosurgery (product code GZT), Class II - Special Controls.

Submitted by Medicon EG (Tuttlingen, DE). The FDA issued a Cleared decision on March 24, 2017 after a review of 280 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4800 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K161680

510(k) Number K161680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 149d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZT Device Classification - Class 2, Special Controls

Product Code GZT Retractor, Self-retaining, For Neurosurgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Consultant

The OrthoMedix Group, Inc.
J. D. Webb

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GZT Retractor, Self-retaining, For Neurosurgery

All 34
Devices cleared under the same product code (GZT) and FDA review panel - the closest regulatory comparables to K161680.
MindsEye Expandable Port
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Geister retractor for neuro - and spine surgery
K180610 · Geister Medizin Technik GmbH · Aug 2018
NICO BrainPath
K172433 · Nico Corporation · Sep 2017
Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems
K161318 · Tedan Surgical Innovations, LLC · Mar 2017
Self-retaining Retractor
K161004 · Fetzer Medical GmbH & Co. KG · Sep 2016
NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook
K150378 · Nico Corporation · Jun 2015