Cleared Traditional

K143028 - Azure Anterior Cervical Plate System

K143028 is an FDA 510(k) clearance for Azure Anterior Cervical Plate System, manufactured by Orthofix, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K143028 · Orthofix, Inc. · Orthopedic device
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May 2015
Decision
220d
Days
Class 2
Risk

K143028 is an FDA 510(k) clearance for the Azure Anterior Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Orthofix, Inc. (Lewisville, US). The FDA issued a Cleared decision on May 29, 2015 after a review of 220 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 Orthofix, Inc. devices

FDA 510(k) Submission Details - K143028

510(k) Number K143028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2014
Decision Date May 29, 2015
Days to Decision 220 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
98d slower than avg
Panel avg: 122d · This submission: 220d
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 589
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K143028.
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uNion Cervical Plate System
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Captiva Spine SmartLOX Cervical Plate System
K141332 · Captiva Spine · Jun 2015
Blue Mountain Cervical Plate System
K150036 · Spineway · May 2015
Pyrenees Cervical Plate System
K142212 · K2m, Inc. · May 2015
FortiBridge Anterior Cervical Plate System
K143706 · Nanovis Spine, LLC · Apr 2015