Cleared Special

K120352 - STRYKER QUIKFLAP STERILE PROCEDURE PACK

K120352 is the FDA 510(k) clearance for STRYKER QUIKFLAP STERILE PROCEDURE PACK by Stryker. It is a Class 2 Neurology device (product code GWO) cleared through the Special 510(k) pathway after a 126-day FDA review.

K120352 · Stryker · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
126d
Days
Class 2
Risk

K120352 is an FDA 510(k) clearance for the STRYKER QUIKFLAP STERILE PROCEDURE PACK. Classified as Plate, Cranioplasty, Preformed, Alterable (product code GWO), Class II - Special Controls.

Submitted by Stryker (Porage, US). The FDA issued a Cleared decision on June 11, 2012 after a review of 126 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stryker devices

Submission Details

510(k) Number K120352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2012
Decision Date June 11, 2012
Days to Decision 126 days
Submission Type Special
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
22d faster than avg
Panel avg: 148d · This submission: 126d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 25
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