Cleared Special

K051815 - MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM

K051815 is an FDA 510(k) clearance for MODIFICATION TO VERTEBRON SCP CERVICAL ..., 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 104-day FDA review.

K051815 · Vertebron, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
104d
Days
Class 2
Risk

K051815 is an FDA 510(k) clearance for the MODIFICATION TO 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 October 17, 2005 after a review of 104 days - within the typical 510(k) review window.

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. 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 - K051815

510(k) Number K051815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2005
Decision Date October 17, 2005
Days to Decision 104 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
18d faster than avg
Panel avg: 122d · This submission: 104d
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 663
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K051815.
STELLA CERVICAL PLATE
K052763 · Scient'X · Nov 2005
SPIDER CERVICAL PLATING (SCP) SYSTEM
K052292 · X-Spine Systems, Inc. · Oct 2005
TECTONIC CERVICAL PLATE SYSTEM
K051531 · K2m, LLC · Oct 2005
HYBRID ANTERIOR CERVICAL PLATE SYSTEM
K052552 · Depuy Spine, Inc. · Oct 2005
SYNTHES VECTRA-T SYSTEM
K051665 · Synthes Spine · Sep 2005
THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE LEVEL PLATES
K052072 · Abbott Spine, Inc. · Aug 2005
K051815 · MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM
Download PDF FDA Summary Vertebron, Inc.