Cleared Traditional

K192314 - RESONATE Anterior Cervical Plate System

K192314 is the FDA 510(k) clearance for RESONATE 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 58-day FDA review.

K192314 · Globus Medical, Inc. · Orthopedic device
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Oct 2019
Decision
58d
Days
Class 2
Risk

K192314 is an FDA 510(k) clearance for the RESONATE 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 October 23, 2019 after a review of 58 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Globus Medical, Inc. devices

Submission Details

510(k) Number K192314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2019
Decision Date October 23, 2019
Days to Decision 58 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
64d faster than avg
Panel avg: 122d · This submission: 58d
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 K192314.
Oryx Cervical Plate System
K192049 · Innovasis, Inc. · Nov 2019
NexGen Anterior Cervical Plate System
K192494 · Precision Spine · Oct 2019
Genesys Spine Binary® Lumbar Plate System
K192678 · Genesys Spine · Oct 2019
FORTICO Anterior Cervical Fixation System
K191584 · Camber Spine Technologies, LLC · Oct 2019
NuVasive® ACP System
K191500 · Nu Vasive, Incorporated · Sep 2019
Cyclops™ Anterior Cervical Plate System
K191786 · Degen Medical, Inc. · Aug 2019