Cleared Traditional

K103423 - MIS ANTERIOR CERVICAL PLATING SYSTEM

K103423 is an FDA 510(k) clearance for MIS ANTERIOR CERVICAL PLATING SYSTEM, manufactured by Life Spine. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K103423 · Life Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
191d
Days
Class 2
Risk

K103423 is an FDA 510(k) clearance for the MIS ANTERIOR CERVICAL PLATING 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 June 1, 2011 after a review of 191 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Life Spine devices

FDA 510(k) Submission Details - K103423

510(k) Number K103423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2010
Decision Date June 01, 2011
Days to Decision 191 days
Submission Type Traditional
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
69d slower than avg
Panel avg: 122d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 622
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K103423.
GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM
K110990 · Gold Standard Orthopedics, LLC · Jul 2011
NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM
K111866 · Nuvasive, Inc. · Jul 2011
NUVASIVE LONG LATERAL SPINAL SYSTEM
K111410 · Nuvasive, Inc. · Jun 2011
ALTUM ANTERIOR CERVICAL PLATE
K103505 · Spinecraft, LLC · Mar 2011
NUVASIVE TRAVERSE PLATE SYSTEM
K103750 · Nuvasive, Inc. · Mar 2011
PSL ANTERIOR CERVICAL PLATE SYSTEM
K103819 · Precision Surgery , Ltd. · Feb 2011