Cleared Special

K062407 - GATEWAY THORACOLUMBAR PLATE SYSTEM

K062407 is the FDA 510(k) clearance for GATEWAY THORACOLUMBAR PLATE SYSTEM by Globus Medical, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Special 510(k) pathway after a 20-day FDA review.

K062407 · Globus Medical, Inc. · Orthopedic device
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Sep 2006
Decision
20d
Days
Class 2
Risk

K062407 is an FDA 510(k) clearance for the GATEWAY THORACOLUMBAR PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Phoenixville, US). The FDA issued a Cleared decision on September 6, 2006 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Globus Medical, Inc. devices

Submission Details

510(k) Number K062407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2006
Decision Date September 06, 2006
Days to Decision 20 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 122d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 Orthopedic devices follow this clearance model.

Regulatory Peers - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 438
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K062407.
CITADEL ANTERIOR LUMBAR PLATE SYSTEM
K062836 · Globus Medical, Inc. · Dec 2006
KINETIC ANTERIOR CERVICAL PLATE
K062643 · Life Spine · Nov 2006
MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM
K062831 · Life Spine · Oct 2006
TRINICA ANTERIOR LUMBAR PLATE SYSTEM
K061353 · Zimmer Spine, Inc. · Aug 2006
REFLEX HYBRID ACP SYSTEM
K062310 · Stryker Spine · Aug 2006
LATERAL PLATE SYSTEM
K061789 · Nuvasive, Inc. · Aug 2006