Cleared Traditional

K192494 - NexGen Anterior Cervical Plate System

K192494 is the FDA 510(k) clearance for NexGen Anterior Cervical Plate System by Precision Spine. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K192494 · Precision Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2019
Decision
48d
Days
Class 2
Risk

K192494 is an FDA 510(k) clearance for the NexGen Anterior Cervical Plate System. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Precision Spine (Pear, US). The FDA issued a Cleared decision on October 29, 2019 after a review of 48 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 Precision Spine devices

Submission Details

510(k) Number K192494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2019
Decision Date October 29, 2019
Days to Decision 48 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
74d faster than avg
Panel avg: 122d · This submission: 48d
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 Consultant

The OrthoMedix Group, Inc.
J. D. Webb

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 421
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K192494.
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FORTICO Anterior Cervical Fixation System
K191584 · Camber Spine Technologies, LLC · Oct 2019