Cleared Special

K061938 - VERTE-STACK SPINAL SYSTEM

K061938 is the FDA 510(k) clearance for VERTE-STACK SPINAL SYSTEM by Medtronic Sofamor Danek, Inc.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Special 510(k) pathway after a 30-day FDA review.

K061938 · Medtronic Sofamor Danek, Inc. · Orthopedic device
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Aug 2006
Decision
30d
Days
Class 2
Risk

K061938 is an FDA 510(k) clearance for the VERTE-STACK SPINAL SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek, Inc. (Memphis, US). The FDA issued a Cleared decision on August 9, 2006 after a review of 30 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, Inc. devices

Submission Details

510(k) Number K061938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2006
Decision Date August 09, 2006
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 K061938.
VERTE-STACK SPINAL SYSTEM
K062427 · Medtronic Sofamor Danek · Sep 2006
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VERTE-STACK SPINAL SYSTEM
K062073 · Medtronic Sofamor Danek · Aug 2006
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K061836 · Stryker Spine · Aug 2006
PIONEER VERTEBRAL SPACER (VERTEBRAL SPACER)
K061151 · Pioneer Surgical Technology · Jul 2006
EBI ESL PEEK-OPTIMA SPINE SYSTEM
K061016 · Ebi, L.P. · Jun 2006