Cleared Traditional

K202972 - Anterior Cervical Plate System

K202972 is the FDA 510(k) clearance for Anterior Cervical Plate System by Nutech Spine and Biologics. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K202972 · Nutech Spine and Biologics · Orthopedic device
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Nov 2020
Decision
55d
Days
Class 2
Risk

K202972 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 Nutech Spine and Biologics (Birmingham, US). The FDA issued a Cleared decision on November 24, 2020 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 Nutech Spine and Biologics devices

Submission Details

510(k) Number K202972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2020
Decision Date November 24, 2020
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.

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

Surgop Support
Daniel Lanois

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 K202972.
Lumbar Spine Truss System Plating Solution (LSTS-PS)
K203065 · 4Web, Inc. · Mar 2021
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NuVasive ACP System
K203253 · Nu Vasive, Incorporated · Dec 2020
KASILOF Cervical Plate System
K203154 · Kahtnu Surgical, Inc. · Nov 2020
Z-Span Plate System
K202624 · Zavation Medical Products, LLC · Nov 2020
icotec Anterior Cervical Plate System
K201587 · Icotec AG · Oct 2020