Cleared Special

K062110 - VERTEBRON SCP CERVICAL PLATE SYSTEM

K062110 is an FDA 510(k) clearance for VERTEBRON SCP CERVICAL PLATE SYSTEM, manufactured by Vertebron, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 23-day FDA review.

K062110 · Vertebron, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
23d
Days
Class 2
Risk

K062110 is an FDA 510(k) clearance for the VERTEBRON SCP CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Vertebron, Inc. (Stratford, US). The FDA issued a Cleared decision on August 16, 2006 after a review of 23 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 Vertebron, Inc. devices

FDA 510(k) Submission Details - K062110

510(k) Number K062110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2006
Decision Date August 16, 2006
Days to Decision 23 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 122d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

KWQ Device Classification - Class 2, Special Controls

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 513
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K062110.
GATEWAY THORACOLUMBAR PLATE SYSTEM
K062407 · Globus Medical, Inc. · Sep 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
UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM
K061229 · Blackstone Medical, Inc. · Jul 2006
OPTERYX ANTERIOR CERVICAL PLATE SYSTEM
K061147 · Innovasis, Inc. · Jun 2006