FDA.reportPublic FDA data

510(k) K231850

Device
QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments
Applicant
Globus Medical, Inc.
510(k) number
K231850
Product code
NKG
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-14
Date received
2023-06-23
Regulation
888.3075
Classification name
Posterior Cervical Screw System
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jennifer Antonacci
Address
2560 General Armistead Ave. Audubon PA US 19403 19403

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NKG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.2025-10-24
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K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC2025-05-20
K242674Freedom Posterior Cervical ScrewsSignature Orthopaedics Pty, Ltd.2025-05-13
K250332Virage® OCT Spinal Fixation SystemHighridge Medical, LLC2025-04-04
K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC2024-11-19
K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.2024-03-27
K233332Statera-C™ Spinal SystemK&J Consulting Corp.2023-11-27
K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.2023-11-22
K233366SYMPHONY OCT SystemMedos International SARL2023-11-09
K232167VySpan™ PCT SystemVy Spine, LLC2023-09-27
K231654NorthStar OCT SystemSeaspine, Inc.2023-08-03