Cleared Traditional

K140563 - LATERAL VBR SYSTEM

K140563 is an FDA 510(k) clearance for LATERAL VBR SYSTEM, manufactured by Nu Vasive, Incorporated. The device is a Class 2 Orthopedic device with product code MQP cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K140563 · Nu Vasive, Incorporated · Orthopedic device
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Aug 2014
Decision
155d
Days
Class 2
Risk

K140563 is an FDA 510(k) clearance for the LATERAL VBR SYSTEM. Classified as Spinal Vertebral Body Replacement Device (product code MQP), Class II - Special Controls.

Submitted by Nu Vasive, Incorporated (San Diego, US). The FDA issued a Cleared decision on August 7, 2014 after a review of 155 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 Nu Vasive, Incorporated devices

FDA 510(k) Submission Details - K140563

510(k) Number K140563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2014
Decision Date August 07, 2014
Days to Decision 155 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 122d · This submission: 155d
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 262
Devices cleared under the same product code (MQP) and FDA review panel - the closest regulatory comparables to K140563.
STGC-LORDOTIC
K142030 · Cardinal Spine, LLC · Jan 2015
CAPRI
K142016 · K2m, Inc. · Nov 2014
AIS MODULIFT VBR SYSTEM
K142150 · Aesculap Implant System, Inc. · Oct 2014
AIS MODULIFT VBR SYSTEM
K133802 · Aesculap Implant System, Inc. · Apr 2014
TASMIN R
K123758 · Signus Medizintechnik GmbH · Jan 2014
PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE
K131724 · Pioneer Surgical Technology, Inc. · Dec 2013