Cleared Special

K073517 - H-LINK INTEGRATED ROD

K073517 is the FDA 510(k) clearance for H-LINK INTEGRATED ROD by Globus Medical, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Special 510(k) pathway after a 20-day FDA review.

K073517 · Globus Medical, Inc. · Orthopedic device
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Jan 2008
Decision
20d
Days
Class 2
Risk

K073517 is an FDA 510(k) clearance for the H-LINK INTEGRATED ROD. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on January 3, 2008 after a review of 20 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 Globus Medical, Inc. devices

Submission Details

510(k) Number K073517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2007
Decision Date January 03, 2008
Days to Decision 20 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
102d faster than avg
Panel avg: 122d · This submission: 20d
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 K073517.
ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM
K073510 · Endius, Inc. · Feb 2008
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
K073267 · Endius, Inc. · Jan 2008
LIFE SPINE CROSS CONNECTOR
K073480 · Life Spine · Jan 2008
BEACON STABILIZATION SYSTEM
K073172 · Globus Medical, Inc. · Dec 2007
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
K072840 · Endius, Inc. · Dec 2007
EXPEDIUM SPINE SYSTEM
K073126 · Depuy Spine, Inc. · Dec 2007