Cleared Traditional

K141632 - ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM

K141632 is an FDA 510(k) clearance for ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM, manufactured by Medtronic Sofamor Danek USA, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K141632 · Medtronic Sofamor Danek USA, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
169d
Days
Class 2
Risk

K141632 is an FDA 510(k) clearance for the ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on December 4, 2014 after a review of 169 days - an extended review 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: 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 Medtronic Sofamor Danek USA, Inc. devices

FDA 510(k) Submission Details - K141632

510(k) Number K141632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2014
Decision Date December 04, 2014
Days to Decision 169 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
47d slower than avg
Panel avg: 122d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

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 599
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K141632.
Aviator Anterior Cervical Plate (ACP) System
K142237 · Stryker Corporation · Jan 2015
NuVasive ALIF Buttress Plate System
K143065 · Nu Vasive, Incorporated · Jan 2015
LITe Plate System
K142699 · Stryker Corporation · Dec 2014
TRANSOM ANTERIOR CERVICAL PLATE
K142060 · Neurostructures, Inc. · Nov 2014
NAKOMA ACP
K141993 · Alliance Partners, LLC · Nov 2014
MAXAN ANTERIOR CERVICAL PLATE SYSTEM
K133518 · Biomet Spine (Aka Ebi, LLC) · Nov 2014