Cleared Special

K043566 - MODIFICATION TO VERTE-STACK SPINAL SYSTEM

K043566 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 11-day FDA review.

K043566 · Medtronic Sofamor Danek · Orthopedic device
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Jan 2005
Decision
11d
Days
Class 2
Risk

K043566 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 January 7, 2005 after a review of 11 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 K043566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2004
Decision Date January 07, 2005
Days to Decision 11 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
111d faster than avg
Panel avg: 122d · This submission: 11d
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 K043566.
STRYKER SPINE AVS TL PEEK SPACER
K042571 · Stryker Spine · Feb 2005
NUVASIVE COROENT SYSTEM
K043405 · Nuvasive, Inc. · Feb 2005
PIONEER VERTEBRAL BODY REPLACEMENT DEVICE (PIONEER VERTEBRAL SPACER)
K043206 · Pioneer Surgical Technology · Jan 2005
TITANIUM MESH IMPLANT
K041407 · Interpore Cross Intl. · Dec 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K043561 · Medtronic Sofamor Danek · Dec 2004
EBI CAS SPINE SPACER SYSTEM
K042268 · Ebi, L.P. · Oct 2004