Cleared Special

K083389 - COALITION SPACER

K083389 is the FDA 510(k) clearance for COALITION SPACER by Globus Medical, Inc.. It is a Class 2 Orthopedic device (product code OVE) cleared through the Special 510(k) pathway after a 129-day FDA review.

K083389 · Globus Medical, Inc. · Orthopedic device
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Mar 2009
Decision
129d
Days
Class 2
Risk

K083389 is an FDA 510(k) clearance for the COALITION SPACER. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on March 26, 2009 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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. Standard predicate reliance. 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 K083389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2008
Decision Date March 26, 2009
Days to Decision 129 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
7d slower than avg
Panel avg: 122d · This submission: 129d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 115
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K083389.
COROENT INTERLOCK SYSTEM
K102547 · Nuvasive, Inc. · Feb 2011
SYNTHES ZERO-P
K093762 · Synthes Spine · Dec 2010
PEEK PREVAIL CERVICAL INTERBODY DEVICE
K094042 · Medtronic Sofamor Danek · Jun 2010
PEEK PREVAIL CERVICAL INTERBODY DEVICE
K073285 · Medtronic Sofamor Danek USA, Inc. · May 2008
MOSAIC DEVICES
K071833 · Spinal Elements, Inc. · Oct 2007