Cleared Traditional

K143626 - inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System

K143626 is an FDA 510(k) clearance for inVizia Anterior Certical Plate System, manufactured by Zimmer Spine, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K143626 · Zimmer Spine, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2015
Decision
88d
Days
Class 2
Risk

K143626 is an FDA 510(k) clearance for the inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Pl.... Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Zimmer Spine, Inc. (Minneapolis, US). The FDA issued a Cleared decision on March 20, 2015 after a review of 88 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 Zimmer Spine, Inc. devices

FDA 510(k) Submission Details - K143626

510(k) Number K143626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2014
Decision Date March 20, 2015
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 602
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K143626.
Pyrenees Cervical Plate System
K142212 · K2m, Inc. · May 2015
FortiBridge Anterior Cervical Plate System
K143706 · Nanovis Spine, LLC · Apr 2015
LnK Anterior Cervical Plate System
K143279 · L & K Biomed Co., Ltd. · Mar 2015
LITe Plate System
K150449 · Stryker Corp. · Mar 2015
Exactech Ambassador
K143576 · Exactech, Inc. · Feb 2015
Aviator Anterior Cervical Plate (ACP) System
K142237 · Stryker Corporation · Jan 2015