FDA.report

510(k) K250332

Device
Virage® OCT Spinal Fixation System
Applicant
Highridge Medical, LLC
510(k) number
K250332
Product code
NKG
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-04
Date received
2025-02-05
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
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Regan Ream
Address
10225 Westmoor Dr. Westminister CO US 80021 80021

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
03662663080071Virage® OCTHighridge Medical, LLC2025-06-03
03662663080101Virage® OCTHighridge Medical, LLC2025-04-24
03662663080088Virage OCT Spinal Fixation SystemHighridge Medical, LLC2025-04-24
03662663080064Virage® OCTHighridge Medical, LLC2025-04-24
03662663080057Virage® OCTHighridge Medical, LLC2025-04-24
03662663079846Virage® OCTHighridge Medical, LLC2025-04-24
03662663079839Virage® OCTHighridge Medical, LLC2025-04-24
03662663079822Virage® OCTHighridge Medical, LLC2025-04-24
03662663079815Virage® OCTHighridge Medical, LLC2025-04-24

Other 510(k) Records For Product Code NKG

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
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
K231654NorthStar OCT SystemSeaspine, Inc.2023-08-03