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510(k) K222107

Device
Black Diamond™ POCT Spinal System
Applicant
Osseus Fusion Systems
510(k) number
K222107
Product code
NKG  
Decision
Substantially Equivalent (SESE)
Decision date
2022-11-03
Date received
2022-07-18
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
Jonathan Rosen
Address
1931 Greenville Ave. Suite 200 Dallas TX US 75206 75206

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
K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.2026-06-02
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

Legacy Summary#

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FDA Review#

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