Cleared Special

K062686 - UNIVERSAL SPINAL ANTERIOR LOCKING PLATE SYSTEM

K062686 is an FDA 510(k) clearance for UNIVERSAL SPINAL ANTERIOR LOCKING PLATE..., manufactured by Advanced Spine Technology, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 27-day FDA review.

K062686 · Advanced Spine Technology, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
27d
Days
Class 2
Risk

K062686 is an FDA 510(k) clearance for the UNIVERSAL SPINAL ANTERIOR LOCKING PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Advanced Spine Technology, Inc. (Round Rock, US). The FDA issued a Cleared decision on October 5, 2006 after a review of 27 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 - K062686

510(k) Number K062686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2006
Decision Date October 05, 2006
Days to Decision 27 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
95d faster than avg
Panel avg: 122d · This submission: 27d
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 664
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K062686.
MAXIMA ANTERIOR CERVICAL PLATE SYSTEM
K061002 · U&I Corp. · Nov 2006
SYNTHES ANTEGRA SYSTEM
K063158 · Synthes Spine Co.Lp · Nov 2006
MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM
K062831 · Life Spine · Oct 2006
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
K062686 · UNIVERSAL SPINAL ANTERIOR LOCKING PLATE SYSTEM
Download PDF FDA Summary Advanced Spine Techno…