Cleared Traditional

K080664 - RELIEVE LAMINOPLASTY FIXATION SYSTEM

K080664 is the FDA 510(k) clearance for RELIEVE LAMINOPLASTY FIXATION SYSTEM by Globus Medical, Inc.. It is a Class 2 Orthopedic device (product code NQW) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K080664 · Globus Medical, Inc. · Orthopedic device
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Jul 2008
Decision
137d
Days
Class 2
Risk

K080664 is an FDA 510(k) clearance for the RELIEVE LAMINOPLASTY FIXATION SYSTEM. Classified as Orthosis, Spine, Plate, Laminoplasty, Metal (product code NQW), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on July 25, 2008 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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 Globus Medical, Inc. devices

Submission Details

510(k) Number K080664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2008
Decision Date July 25, 2008
Days to Decision 137 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
15d slower than avg
Panel avg: 122d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NQW Orthosis, Spine, Plate, Laminoplasty, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
Definition This Device Is A Plate That Is Attached To The Lamina After A Laminoplasty Or Laminectomy Procedure.
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 - NQW Orthosis, Spine, Plate, Laminoplasty, Metal

All 19
Devices cleared under the same product code (NQW) and FDA review panel - the closest regulatory comparables to K080664.
ESCALATE LAMINOPLASTY SYSTEM
K113802 · Stryker Spine · Apr 2012
MOUNTAINEER LAMINOPLASTY SYSTEM
K091994 · Depuy Spine, Inc. · Jan 2010
LAMINOPLASTY FIXATION SYSTEM
K091623 · Nuvasive, Inc. · Oct 2009
CENTERPIECE PLATE FIXATION SYSTEM
K050082 · Medtronic Sofamor Danek, Inc. · Jun 2005
BLAKSTONE LAMINOPLASTY FIXATION SYSTEM
K043338 · Blackstone Medical, Inc. · Feb 2005
SYNTHES AFS
K032534 · Synthes Spine · Apr 2004