Cleared Special

K060719 - MODIFICATION TO VERTE-STACK SPINAL SYSTEM

K060719 is the FDA 510(k) clearance for MODIFICATION TO VERTE-STACK SPINAL SYSTEM by Medtronic Sofamor Danek. It is a Class 2 Orthopedic device (product code MQP) cleared through the Special 510(k) pathway after a 28-day FDA review.

K060719 · Medtronic Sofamor Danek · Orthopedic device
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Apr 2006
Decision
28d
Days
Class 2
Risk

K060719 is an FDA 510(k) clearance for the MODIFICATION TO VERTE-STACK SPINAL SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on April 14, 2006 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic Sofamor Danek devices

Submission Details

510(k) Number K060719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2006
Decision Date April 14, 2006
Days to Decision 28 days
Submission Type Special
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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MQP Spinal Vertebral Body Replacement Device
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 - MQP Spinal Vertebral Body Replacement Device

All 158
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K060719.
STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM
K060506 · Stryker Spine · May 2006
XPAND RADIOLUCENT CORPECTOMY SPACER
K060665 · Globus Medical, Inc. · May 2006
STAXX XD SYSTEM
K052670 · Spine Wave, Inc. · Apr 2006
CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM
K060350 · Blackstone Medical, Inc. · Feb 2006
NUVASIVE COROENT EXTENSURE SYSTEM
K052210 · Nuvasive, Inc. · Dec 2005
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K052931 · Medtronic Sofamor Danek · Nov 2005