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510(k) K190895

Device
MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System
Applicant
Medos International Sarl
510(k) number
K190895
Product code
NKG  
Decision
Substantially Equivalent (SESE)
Decision date
2019-07-18
Date received
2019-04-05
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
Sheree Geller
Address
Chemin-Blanc 38 Le Locle CH 2400 2400

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
K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.2026-03-16
K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.2026-01-21
K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG2025-11-12
K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.2025-10-24
K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.2025-06-25
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
K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.2024-03-14
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

Legacy Summary#

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FDA Review#

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