Cleared Traditional

K151312 - VerteLP Interbody Fusion Device

K151312 is an FDA 510(k) clearance for VerteLP Interbody Fusion Device, manufactured by Vgi, LLC. The device is a Class 2 Orthopedic device with product code OVD cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K151312 · Vgi, LLC · Orthopedic device
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Jan 2016
Decision
240d
Days
Class 2
Risk

K151312 is an FDA 510(k) clearance for the VerteLP Interbody Fusion Device. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Vgi, LLC (St. Petersburg, US). The FDA issued a Cleared decision on January 13, 2016 after a review of 240 days - an extended review cycle.

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 Vgi, LLC devices

FDA 510(k) Submission Details - K151312

510(k) Number K151312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2015
Decision Date January 13, 2016
Days to Decision 240 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
118d slower than avg
Panel avg: 122d · This submission: 240d
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 167
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K151312.
MectaLIF Anterior Stand-Alone
K160605 · Medacta International · Jul 2016
TransContinental® M Spacers and InterContinental® Plate-Spacers
K161223 · Globus Medical, Inc. · Jul 2016
NuVasive® Interfixated Interbody System
K160051 · Nu Vasive, Incorporated · Apr 2016
Sahara Stabilization System
K151481 · K2m, Inc. · Dec 2015
NuVasive Foundation-LL System
K152943 · Nu Vasive, Incorporated · Dec 2015
SYNFIX Evolution Secured Spacer System
K150673 · Synthes USA Products, LLC · Aug 2015