Cleared Traditional

K212446 - NuVasive Anterior Cervical Plate Systems

K212446 is the FDA 510(k) clearance for NuVasive Anterior Cervical Plate Systems by Nu Vasive, Incorporated. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K212446 · Nu Vasive, Incorporated · Orthopedic device
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Nov 2021
Decision
90d
Days
Class 2
Risk

K212446 is an FDA 510(k) clearance for the NuVasive Anterior Cervical Plate Systems. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on November 3, 2021 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Nu Vasive, Incorporated devices

Submission Details

510(k) Number K212446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2021
Decision Date November 03, 2021
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 435
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K212446.
Xenco Medical Multilevel CerviKit
K213456 · Xenco Medical, LLC · Dec 2021
Insignia™ Anterior Cervical Plate System
K213443 · Alphatec Spine, Inc. · Dec 2021
Dakota ALIF Plate System
K212937 · Precision Spine, Inc. · Nov 2021
Quantum Anterior Cervical Plate
K210424 · Nvision Biomedical Technologies, Inc. · Oct 2021
EMERGE™ Anterior Cervical Plate System
K212405 · Evolution Spine · Sep 2021
Admiral ACP System
K212139 · SeaSpine Orthopedics Corporation · Sep 2021