Cleared Traditional

K141644 - INNOVASIS CRANIAL SYSTEM

K141644 is an FDA 510(k) clearance for INNOVASIS CRANIAL SYSTEM, manufactured by Innovasis, Inc.. The device is a Class 2 Neurology device with product code GWO cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K141644 · Innovasis, Inc. · Neurology device
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Nov 2014
Decision
141d
Days
Class 2
Risk

K141644 is an FDA 510(k) clearance for the INNOVASIS CRANIAL SYSTEM. Classified as Plate, Cranioplasty, Preformed, Alterable (product code GWO), Class II - Special Controls.

Submitted by Innovasis, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on November 7, 2014 after a review of 141 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 Innovasis, Inc. devices

FDA 510(k) Submission Details - K141644

510(k) Number K141644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2014
Decision Date November 07, 2014
Days to Decision 141 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
7d faster than avg
Panel avg: 148d · This submission: 141d
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 38
Devices cleared under the same product code (GWO) and FDA review panel - the closest regulatory comparables to K141644.
PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority
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MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)
K140462 · Synthes USA Products, LLC · Jun 2014
UNIVERSAL NEURO 3 SYSTEM
K131775 · Stryker · Oct 2013