Cleared Traditional

K010930 - LIFT VB SPINAL SYSTEM

K010930 is the FDA 510(k) clearance for LIFT VB SPINAL SYSTEM by Medtronic Sofamor Danek, Inc.. It is a Class 2 Orthopedic device (product code MQP) cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K010930 · Medtronic Sofamor Danek, Inc. · Orthopedic device
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Oct 2001
Decision
210d
Days
Class 2
Risk

K010930 is an FDA 510(k) clearance for the LIFT VB 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 October 24, 2001 after a review of 210 days - an extended review 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: 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, Inc. devices

Submission Details

510(k) Number K010930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2001
Decision Date October 24, 2001
Days to Decision 210 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
88d slower than avg
Panel avg: 122d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K010930.
SPINAL MESH SYSTEM
K011406 · Medtronic Sofamor Danek, Inc. · Dec 2001
TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120, 8130, 8131
K010989 · Interpore Cross Intl. · Nov 2001
MODIFICATION TO: STACKABLE CAGE SYSTEM
K013382 · Depuyacromed · Nov 2001
GEO STRUCTURE
K010530 · Interpore Cross Intl. · Aug 2001
SURGICAL DYNAMICS MESH CAGE SYSTEM
K003709 · United States Surgical, A Division of Tyco Healthc · Jul 2001
SURGICAL TITANIUM MESH SYSTEM
K003043 · Depuyacromed · May 2001