Cleared Traditional

K173375 - Anterior Cervical Plate System

K173375 is the FDA 510(k) clearance for Anterior Cervical Plate System by Evolution Spine, LLC. It is a Class 2 Orthopedic device (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

Submission Details

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
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.

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 422
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
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EZ Plate
K173306 · Zavation Medical Products, LLC · Jan 2018
2 Hole Lateral Plating System
K172131 · Life Spine, Inc. · Aug 2017
Ozark(tm) Cervical Plate System
K172104 · K2m, Inc. · Aug 2017
NOOSA Anterior Lumbar Plate System
K163625 · Signature Orthopaedics Pty, Ltd. · Aug 2017