Cleared Traditional

K131775 - UNIVERSAL NEURO 3 SYSTEM

K131775 is an FDA 510(k) clearance for UNIVERSAL NEURO 3 SYSTEM, manufactured by Stryker. The device is a Class 2 Neurology device with product code GWO cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K131775 · Stryker · Neurology device
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Oct 2013
Decision
122d
Days
Class 2
Risk

K131775 is an FDA 510(k) clearance for the UNIVERSAL NEURO 3 SYSTEM. Classified as Plate, Cranioplasty, Preformed, Alterable (product code GWO), Class II - Special Controls.

Submitted by Stryker (Portage, US). The FDA issued a Cleared decision on October 17, 2013 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5320 - 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 Stryker devices

FDA 510(k) Submission Details - K131775

510(k) Number K131775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2013
Decision Date October 17, 2013
Days to Decision 122 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
26d faster than avg
Panel avg: 148d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GWO Device Classification - Class 2, Special Controls

Product Code GWO Plate, Cranioplasty, Preformed, Alterable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5320
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 - GWO Plate, Cranioplasty, Preformed, Alterable

All 35
Devices cleared under the same product code (GWO) and FDA review panel - the closest regulatory comparables to K131775.
INNOVASIS CRANIAL SYSTEM
K141644 · Innovasis, Inc. · Nov 2014
LEFORTE NEURO SYSTEM BONE PLATE AND SCREW
K141452 · Jeil Medical Corporation · Jul 2014
MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)
K140462 · Synthes USA Products, LLC · Jun 2014
NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM
K122049 · Kinamed, Inc. · Apr 2013
RESORB-X G
K121606 · KLS-Martin L.P. · Jan 2013
BIOMET MICROFIXATION NEURO PLATING SYSTEM
K121624 · Biomet Microfixation · Oct 2012