Cleared Traditional

K183214 - Raven Lumbar Plate System

K183214 is the FDA 510(k) clearance for Raven Lumbar Plate System by Choicespine, LP. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K183214 · Choicespine, LP · Orthopedic device
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Jan 2019
Decision
45d
Days
Class 2
Risk

K183214 is an FDA 510(k) clearance for the Raven Lumbar Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Choicespine, LP (Knoxville, US). The FDA issued a Cleared decision on January 3, 2019 after a review of 45 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 Choicespine, LP devices

Submission Details

510(k) Number K183214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2018
Decision Date January 03, 2019
Days to Decision 45 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
77d faster than avg
Panel avg: 122d · This submission: 45d
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 373
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K183214.
Pinehurst Anterior Cervical Plate System
K181190 · Signature Orthopaedics Pty, Ltd. · Jan 2019
CervAlign™ Anterior Cervical Plate System
K183060 · Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · Jan 2019
4CIS® Pinehurst Anterior Cervical Plate system
K182489 · Solco Biomedical Co., Ltd. · Jan 2019
Met One Czar Anterior Cervical Plate System
K180772 · Met One Technologies · Dec 2018
PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems
K182473 · K2m, Inc. · Dec 2018
V3 Segmental Plating System
K182418 · Atlas Spine, Inc. · Nov 2018