Cleared Traditional

K132014 - GSB GLOBAL SPINAL BALANCE SYSTEM

K132014 is the FDA 510(k) clearance for GSB GLOBAL SPINAL BALANCE SYSTEM by Nuvasive, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K132014 · Nuvasive, Inc. · Orthopedic device
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Oct 2013
Decision
122d
Days
Class 2
Risk

K132014 is an FDA 510(k) clearance for the GSB GLOBAL SPINAL BALANCE SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Nuvasive, Inc. (San Diego, US). The FDA issued a Cleared decision on October 31, 2013 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Nuvasive, Inc. devices

Submission Details

510(k) Number K132014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2013
Decision Date October 31, 2013
Days to Decision 122 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
At panel average
Panel avg: 122d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 668
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K132014.
TITLE 2 POLYAXIAL SPINAL SYSTEM
K133086 · Zimmer Spine, Inc. · Nov 2013
CD HORIZON SPINAL SYSTEM
K132639 · Medtronic Sofamor Danek USA, Inc. · Nov 2013
PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
K132884 · Zimmer Spine, Inc. · Nov 2013
NAUTILUS SPINAL SYSTEM
K132866 · Life Spine, Inc. · Oct 2013
CD HORIZON SPINAL SYSTEM
K132471 · Medtronic Sofamor Danek USA, Inc. · Oct 2013
NAUTILUS SPINAL SYSTEM
K132760 · Life Spine, Inc. · Oct 2013