Cleared Special

K023570 - MODIFICATION TO VERTE-STACK SPINAL SYSTEM

K023570 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 26-day FDA review.

K023570 · Medtronic Sofamor Danek · Orthopedic device
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Nov 2002
Decision
26d
Days
Class 2
Risk

K023570 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 November 19, 2002 after a review of 26 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 K023570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2002
Decision Date November 19, 2002
Days to Decision 26 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
96d faster than avg
Panel avg: 122d · This submission: 26d
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 K023570.
SURGICAL TITANIUM MESH SYSTEM
K030249 · Depuyacromed · Feb 2003
DEVEX MESH SYSTEM
K023835 · Depuyacromed · Jan 2003
INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD)
K022143 · Interpore Cross Intl. · Jan 2003
HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
K022563 · Implex Corp. · Aug 2002
VERTE-STACK SPINAL SYSTEM
K021791 · Medtronic Sofamor Danek · Aug 2002
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2
K021967 · Implex Corp. · Jul 2002