Cleared Special

K043181 - MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM

K043181 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 30-day FDA review.

K043181 · Vertebron, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
30d
Days
Class 2
Risk

K043181 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 December 17, 2004 after a review of 30 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.

FDA 510(k) Submission Details - K043181

510(k) Number K043181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2004
Decision Date December 17, 2004
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 K043181.
GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS
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KOBRA GPS FIXATION SYSTEM
K042859 · Medtronic Vertelink, Inc. · Nov 2004
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
K042544 · Depuy Spine, Inc. · Nov 2004
THE TOSCA ANTERIOR CERVICAL PLATE SYSTEM
K043082 · Signus Medizintechnik GmbH · Nov 2004
K043181 · MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM
Download PDF FDA Summary Vertebron, Inc.