Cleared Special

K073479 - KINETIC-SL ANTERIOR CERVICAL PLATE SYSTEM

K073479 is the FDA 510(k) clearance for KINETIC-SL ANTERIOR CERVICAL PLATE SYSTEM by Life Spine. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Special 510(k) pathway after a 29-day FDA review.

K073479 · Life Spine · Orthopedic device
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Jan 2008
Decision
29d
Days
Class 2
Risk

K073479 is an FDA 510(k) clearance for the KINETIC-SL ANTERIOR CERVICAL PLATE SYSTEM. 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 January 9, 2008 after a review of 29 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 K073479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2007
Decision Date January 09, 2008
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
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 K073479.
THOR ANTERIOR PLATING SYSTEM
K073437 · Stryker Spine · Feb 2008
NUVASIVE HELIX MINI ACP SYSTEM
K073275 · Nuvasive, Inc. · Jan 2008
PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM
K072703 · Pioneer Surgical Technology · Jan 2008
SYNTHES VECTRA-ONE SYSTEM
K071667 · Synthes Spine · Nov 2007
PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM
K071416 · Medtronic Sofamor Danek USA, Inc. · Nov 2007
NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM
K072339 · Nuvasive, Inc. · Oct 2007