Cleared Traditional

K130030 - ZAVATION CERVICAL PLATE SYSTEM

K130030 is an FDA 510(k) clearance for ZAVATION CERVICAL PLATE SYSTEM, manufactured by Zavation, LLC. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K130030 · Zavation, LLC · Orthopedic device
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Apr 2013
Decision
111d
Days
Class 2
Risk

K130030 is an FDA 510(k) clearance for the ZAVATION CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Zavation, LLC (Brandon, US). The FDA issued a Cleared decision on April 25, 2013 after a review of 111 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 Zavation, LLC devices

FDA 510(k) Submission Details - K130030

510(k) Number K130030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2013
Decision Date April 25, 2013
Days to Decision 111 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
11d faster than avg
Panel avg: 122d · This submission: 111d
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 487
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K130030.
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K130640 · Medtronic Sofamor Danek USA, Inc. · Jun 2013
AZURE ANTERIOR CERVICAL PLATE SYSTEM
K130825 · Orthofix, Inc. · May 2013
IRIS ANTERIOR CERVICAL PLATE
K130202 · Life Spine, Inc. · Apr 2013
NUVASIVE LONG LATERAL SPINAL SYSTEM
K122081 · Nuvasive, Inc. · Feb 2013
DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM
K123167 · Medos International SARL · Dec 2012
ANODYNE ANTERIOR CERVICAL PLATE SYSTEM
K121514 · Corelink, LLC · Dec 2012