Cleared Traditional

K071033 - T2 XVBR SPINAL SYSTEM

K071033 is an FDA 510(k) clearance for T2 XVBR 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 124-day FDA review.

K071033 · Medtronic Sofamor Danek · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
124d
Days
Class 2
Risk

K071033 is an FDA 510(k) clearance for the T2 XVBR 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 August 14, 2007 after a review of 124 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Sofamor Danek devices

FDA 510(k) Submission Details - K071033

510(k) Number K071033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2007
Decision Date August 14, 2007
Days to Decision 124 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
2d slower than avg
Panel avg: 122d · This submission: 124d
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 K071033.
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT (VBR), MODEL# 06-115, 06-155
K070754 · Zimmer Trabecular Metal Technology · Aug 2007
LDR SPINE ROI-T SYSTEM
K072132 · Ldr Spine USA · Aug 2007
GSO GS1 SPACER
K071274 · Gold Standard Orthopedics, LLC · Aug 2007
VU E*POD VERTEBRAL BODY REPLACEMENT
K071031 · Theken Spine, LLC · Jul 2007
ATLAS SPINE VERTEBRAL BODY REPLACEMENT
K071497 · Atlas Spine, Inc. · Jun 2007
X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT
K070786 · Theken Spine, LLC · Jun 2007