Cleared Traditional

K183056 - ASSURE Anterior Cervical Plate System

K183056 is the FDA 510(k) clearance for ASSURE Anterior Cervical Plate System by Globus Medical, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K183056 · Globus Medical, Inc. · Orthopedic device
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Apr 2019
Decision
168d
Days
Class 2
Risk

K183056 is an FDA 510(k) clearance for the ASSURE® Anterior Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on April 19, 2019 after a review of 168 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 Globus Medical, Inc. devices

Submission Details

510(k) Number K183056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2018
Decision Date April 19, 2019
Days to Decision 168 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
46d slower than avg
Panel avg: 122d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 435
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K183056.
MVP Cervical Plate System
K190170 · GS Medical Co., Ltd. · May 2019
CYGNUS™ Anterior Cervical Plate System
K190666 · MiRus, LLC · May 2019
Boomerang™ Anterior Cervical Plate System
K190227 · Choicespine, LP · May 2019
CastleLoc-P Anterior Cervical Plate System
K190425 · L & K Biomed Co., Ltd. · Mar 2019
SMG Anterior Cervical Plate System
K183073 · Sapphire Medical Group · Feb 2019
Athena II Cervical Plate System
K183409 · Medyssey USA, Inc. · Feb 2019