Cleared Special

K133369 - TIGER SPINE SYSTEM

K133369 is the FDA 510(k) clearance for TIGER SPINE SYSTEM by Corelink, LLC. It is a Class 2 Orthopedic device (product code NKB) cleared through the Special 510(k) pathway after a 74-day FDA review.

K133369 · Corelink, LLC · Orthopedic device
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Jan 2014
Decision
74d
Days
Class 2
Risk

K133369 is an FDA 510(k) clearance for the TIGER SPINE SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Corelink, LLC (Round Rock, US). The FDA issued a Cleared decision on January 14, 2014 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Corelink, LLC devices

Submission Details

510(k) Number K133369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2013
Decision Date January 14, 2014
Days to Decision 74 days
Submission Type Special
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
48d faster than avg
Panel avg: 122d · This submission: 74d
Pathway characteristics
Modification to existing cleared device.

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 K133369.
RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM
K133944 · K2m, Inc. · Mar 2014
ARSENAL SPINAL FIXATION SYSTEM
K133221 · Alphatec Spine, Inc. · Mar 2014
REVERE STABILIZATION SYSTEM
K133350 · Globus Medical, Inc. · Mar 2014
M.U.S.T. EXTENSION
K132878 · Medacta International · Dec 2013
MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL
K133188 · Stryker Spine · Dec 2013
ST360 DEGREES SPINAL FIXATION SYSTEM
K133291 · Zimmer Spine, Inc. · Dec 2013