Cleared Traditional

K201087 - CORBEL Spacers

K201087 is the FDA 510(k) clearance for CORBEL Spacers by Globus Medical, Inc.. It is a Class 2 Orthopedic device (product code OVD) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K201087 · Globus Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2020
Decision
99d
Days
Class 2
Risk

K201087 is an FDA 510(k) clearance for the CORBEL Spacers. Classified as Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on July 31, 2020 after a review of 99 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. 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 K201087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2020
Decision Date July 31, 2020
Days to Decision 99 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
23d faster than avg
Panel avg: 122d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Lumbar 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 - OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar

All 147
Devices cleared under the same product code (OVD) and FDA review panel - the closest regulatory comparables to K201087.
NEXXT MATRIXX Stand Alone ALIF System
K202230 · Nexxt Spine, LLC · Dec 2020
Oculus-SA Lumbar Cage System
K202190 · Neurostructures · Oct 2020
Monterey AL Interbody System
K201585 · Stryker Corporation · Aug 2020
Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device
K200002 · 4Web, Inc. · May 2020
Axis Spine Technologies ALIF
K200352 · Axis Spine Technologies, Ltd. · May 2020
Hive™ Stand-alone Anterior Lumbar Interbody System
K200541 · Hd Lifesciences, LLC · Apr 2020