Cleared Special

K062643 - KINETIC ANTERIOR CERVICAL PLATE

K062643 is the FDA 510(k) clearance for KINETIC ANTERIOR CERVICAL PLATE by Life Spine. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Special 510(k) pathway after a 71-day FDA review.

K062643 · Life Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
71d
Days
Class 2
Risk

K062643 is an FDA 510(k) clearance for the KINETIC ANTERIOR CERVICAL PLATE. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Life Spine (Hoffman Estates, US). The FDA issued a Cleared decision on November 16, 2006 after a review of 71 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 Life Spine devices

Submission Details

510(k) Number K062643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2006
Decision Date November 16, 2006
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
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 421
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K062643.
MODIFICATION TO PYRENEES CERVICAL PLATE SYSTEM
K063544 · K2m, Inc. · Feb 2007
NUVASIVE ACP4 SYSTEM
K062590 · Nuvasive, Inc. · Jan 2007
CITADEL ANTERIOR LUMBAR PLATE SYSTEM
K062836 · Globus Medical, Inc. · Dec 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