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)
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.

View all Medicon EG devices

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
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 148d · 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 Peers - GZT Retractor, Self-retaining, For Neurosurgery

All 17
Devices cleared under the same product code (GZT) and FDA review panel - the closest regulatory comparables to K161680.
Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)
K202694 · Vycor Medical, Inc. · Jan 2021
MindsEye Expandable Port
K202072 · Minnetronix Neuro, Inc. · Aug 2020
Geister retractor for neuro - and spine surgery
K180610 · Geister Medizin Technik GmbH · Aug 2018
SCALP DURA RETRACTOR, MODEL KS00474
K093054 · KARL STORZ Endoscopy-America, Inc. · Nov 2010
SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)
K090272 · Cardinal Health, Inc. · Mar 2009
PIPELINE II ACCESS SYSTEM
K062814 · Depuy Spine, Inc. · Dec 2006