Cleared Special

K112812 - LEFORTE NEURO SYSTEM BONE PLATE

K112812 is an FDA 510(k) clearance for LEFORTE NEURO SYSTEM BONE PLATE, manufactured by Jeil Medical Corporation. The device is a Class 2 Neurology device with product code GWO cleared through the Special 510(k) pathway after a 148-day FDA review.

K112812 · Jeil Medical Corporation · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
148d
Days
Class 2
Risk

K112812 is an FDA 510(k) clearance for the LEFORTE NEURO SYSTEM BONE PLATE. Classified as Plate, Cranioplasty, Preformed, Alterable (product code GWO), Class II - Special Controls.

Submitted by Jeil Medical Corporation (Norcross, US). The FDA issued a Cleared decision on February 22, 2012 after a review of 148 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.

FDA 510(k) Submission Details - K112812

510(k) Number K112812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2011
Decision Date February 22, 2012
Days to Decision 148 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
1d faster than avg
Panel avg: 149d · This submission: 148d
Pathway characteristics
Modification to existing cleared device.

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 43
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K112812 · LEFORTE NEURO SYSTEM BONE PLATE
Download PDF FDA Summary Jeil Medical Corporat…