Cleared Traditional

K173375 - Anterior Cervical Plate System

K173375 is an FDA 510(k) clearance for Anterior Cervical Plate System, manufactured by Evolution Spine, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K173375 · Evolution Spine, LLC · Orthopedic device
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Dec 2017
Decision
55d
Days
Class 2
Risk

K173375 is an FDA 510(k) clearance for the Anterior Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Evolution Spine, LLC (Dallas, US). The FDA issued a Cleared decision on December 21, 2017 after a review of 55 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 Evolution Spine, LLC devices

FDA 510(k) Submission Details - K173375

510(k) Number K173375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2017
Decision Date December 21, 2017
Days to Decision 55 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
67d faster than avg
Panel avg: 122d · This submission: 55d
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 583
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K173375.
TRYPTIK2 C-Plate Anterior Cervical Plate System
K171797 · Spineart · Feb 2018
SeaSpine Cabo ACP (Anterior Cervical Plate) System
K173521 · SeaSpine Orthopedics Corporation · Jan 2018
EZ Plate
K173306 · Zavation Medical Products, LLC · Jan 2018
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
Liberty Anterior Cervical Plate
K172585 · Valorus Spine · Oct 2017