Cleared Traditional

K223753 - Cervical Plate System

K223753 is an FDA 510(k) clearance for Cervical Plate System, manufactured by Double Medical Technology, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K223753 · Double Medical Technology, Inc. · Orthopedic device
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Mar 2023
Decision
90d
Days
Class 2
Risk

K223753 is an FDA 510(k) clearance for the Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Double Medical Technology, Inc. (Xiamen, CN). The FDA issued a Cleared decision on March 14, 2023 after a review of 90 days - within the typical 510(k) review window.

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 Double Medical Technology, Inc. devices

FDA 510(k) Submission Details - K223753

510(k) Number K223753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2022
Decision Date March 14, 2023
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 470
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K223753.
Axis Anterior Cervical Plate System
K231145 · Southern Medical (Pty) , Ltd. · Jun 2023
ATEC Lateral Plate System
K230721 · Alphatec Spine, Inc. · May 2023
Omnia Medical Coupler-A™ Anterior Lumbar Plate System
K230424 · Omnia Medical, LLC · Apr 2023
Omnia Medical Coupler-C Anterior Cervical Plate
K223321 · Omnia Medical, LLC · Mar 2023
Athena III Cervical Plate System
K230301 · Medyssey USA, Inc. · Mar 2023
Magnes-C Anterior Cervical Plate System
K221053 · Fellowship of Orthopaedic Researchers, Inc. · Mar 2023