Cleared Traditional

K062427 - VERTE-STACK SPINAL SYSTEM

K062427 is an FDA 510(k) clearance for VERTE-STACK SPINAL SYSTEM, manufactured by Medtronic Sofamor Danek. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K062427 · Medtronic Sofamor Danek · Orthopedic device
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Sep 2006
Decision
25d
Days
Class 2
Risk

K062427 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 (Memphis, US). The FDA issued a Cleared decision on September 12, 2006 after a review of 25 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Sofamor Danek devices

FDA 510(k) Submission Details - K062427

510(k) Number K062427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2006
Decision Date September 12, 2006
Days to Decision 25 days
Submission Type Traditional
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
97d faster than avg
Panel avg: 122d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQP Device Classification - Class 2, Special Controls

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 259
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K062427.
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K062133 · Medtronic Spinal and Biologics Div · Sep 2006
VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM
K061155 · Zimmer Trabecular · Sep 2006
AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
K060762 · Aesculap, Inc. · Sep 2006
INTERPLATE VBR SYSTEM
K061401 · Rsb Spine, LLC · Aug 2006
SYNEX II
K061891 · Synthes Spine Co.Lp · Aug 2006
AVS PL PEEK SPACER SYSTEM
K062132 · Stryker Spine · Aug 2006