Atlas FDA

Virage® OCT Spinal Fixation System

FDA 510(k) clearance K250332 · decided 2025-04-04

Clearance details

K-number
K250332
Device name
Virage® OCT Spinal Fixation System
Applicant
Highridge Medical, LLC
Decision
Substantially Equivalent
Date received
2025-02-05
Decision date
2025-04-04
Days to decision
58 days
Clearance type
Traditional
Product code
NKG
Device class
2
Regulation number
888.3075
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Westminister, CO, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems (K253195)ZheJiang Decans Medical Devices Co., Ltd.2026-06-02
CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System (K254045)CarboFix Orthopedics , Ltd.2026-03-16
Infinity™ OCT System (K254165)Medtronic Sofamor Danek USA, Inc.2026-01-21
CMORE® CT System; CMORE® CT System Navigated Instruments (K252327)Icotec AG2025-11-12
Infinity™ OCT System (K253129)Medtronic Sofamor Danek USA, Inc.2025-10-24
ANAX™ OCT Spinal System (K251725)Cg Medtech Co., Ltd.2025-06-25
Sovereign Posterior Cervical System (K250866)Met One Technologies, LLC2025-05-20
Freedom Posterior Cervical Screws (K242674)Signature Orthopaedics Pty, Ltd.2025-05-13
EUROPA™ Posterior Cervical Fusion System (K242516)MiRus, LLC2024-11-19
CarboClear® Posterior Cervical Screw System (K233989)CarboFix Orthopedics , Ltd.2024-03-27
QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments (K231850)Globus Medical, Inc.2024-03-14
Statera-C™ Spinal System (K233332)K&J Consulting Corp.2023-11-27

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
LDR Spine Mobi-C® Cervical Disc Prosthesis (P110009/S037)Highridge Medical, LLC2025-10-29
LDR Spine Mobi-C® Cervical Disc Prosthesis (P110002/S037)Highridge Medical, LLC2025-10-29
LDR Spine Mobi-C Cervical Disc Prosthesis (P110009/S036)Highridge Medical, LLC2024-12-02
LDR Spine Mobi-C Cervical Disc Prosthesis (P110002/S036)Highridge Medical, LLC2024-12-02
activL Artificial Disc (P120024/S013)Highridge Medical, LLC2024-01-26
LDR Spine Mobi-C® Cervical Disc Prosthesis (P110009/S035)Highridge Medical, LLC2023-08-01
LDR Spine Mobi-C® Cervical Disc Prosthesis (P110002/S035)Highridge Medical, LLC2023-08-01
LDR Spine Mobi-C Cervical Disc Prosthesis (One Level) (P110002/S033)Highridge Medical, LLC2023-01-12