Cleared Traditional

K173306 - EZ Plate

K173306 is an FDA 510(k) clearance for EZ Plate, manufactured by Zavation Medical Products, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K173306 · Zavation Medical Products, LLC · Orthopedic device
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Jan 2018
Decision
96d
Days
Class 2
Risk

K173306 is an FDA 510(k) clearance for the EZ Plate. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Zavation Medical Products, LLC (Flowood, US). The FDA issued a Cleared decision on January 22, 2018 after a review of 96 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 Zavation Medical Products, LLC devices

FDA 510(k) Submission Details - K173306

510(k) Number K173306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2017
Decision Date January 22, 2018
Days to Decision 96 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
26d faster than avg
Panel avg: 122d · This submission: 96d
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 586
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K173306.
Zavation Buttress Plate System
K180537 · Zavation Medical Products, LLC · Mar 2018
TRYPTIK2 C-Plate Anterior Cervical Plate System
K171797 · Spineart · Feb 2018
SeaSpine Cabo ACP (Anterior Cervical Plate) System
K173521 · SeaSpine Orthopedics Corporation · Jan 2018
Anterior Cervical Plate System
K173375 · Evolution Spine, LLC · Dec 2017
Boundary Anterior Lumbar Buttress Plate
K173091 · Nvision Biomedical Technologies, LLC · Dec 2017
Fortis and Hana Anterior Cervical Plate System
K173099 · Huvexel Co. , Ltd. · Nov 2017