Cleared Traditional

K161524 - Tangis Anterior Cervical Plate

K161524 is the FDA 510(k) clearance for Tangis Anterior Cervical Plate by Nvision Biomedical Technologies, LLC. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K161524 · Nvision Biomedical Technologies, LLC · Orthopedic device
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Sep 2016
Decision
92d
Days
Class 2
Risk

K161524 is an FDA 510(k) clearance for the Tangis Anterior Cervical Plate. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Nvision Biomedical Technologies, LLC (San Antonio, US). The FDA issued a Cleared decision on September 2, 2016 after a review of 92 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 Nvision Biomedical Technologies, LLC devices

Submission Details

510(k) Number K161524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2016
Decision Date September 02, 2016
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
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 K161524.
Terrace™ Anterior Cervical Plate System
K163104 · Corelink, LLC · Jun 2017
CETRA Anterior Cervical Plate System
K162638 · Orthofix, Inc. · Dec 2016
Pyrenees Cervical Plate System
K162664 · K2m, Inc. · Oct 2016
TRYPTIK2C-plate Anterior Cervical Plate System
K153042 · Spineart · Mar 2016
Cam Lock Plating System
K152282 · Life Spine, Inc. · Nov 2015
ATLANTIS Anterior Cervical Plate System
K152623 · Medtronic Sofamor Danek USA, Inc. · Nov 2015