Cleared Traditional

K142271 - Zavation Z-Link Lumbar

K142271 is an FDA 510(k) clearance for Zavation Z-Link Lumbar, manufactured by Zavation, LLC. The device is a Class 2 Orthopedic device with product code OVD cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K142271 · Zavation, LLC · Orthopedic device
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Dec 2014
Decision
126d
Days
Class 2
Risk

K142271 is an FDA 510(k) clearance for the Zavation Z-Link Lumbar. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Zavation, LLC (Flowood, US). The FDA issued a Cleared decision on December 19, 2014 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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 - K142271

510(k) Number K142271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2014
Decision Date December 19, 2014
Days to Decision 126 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
4d slower than avg
Panel avg: 122d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OVD Device Classification - Class 2, Special Controls

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 165
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K142271.
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