FDA.report

510(k) K254165

Device
Infinity™ OCT System
Applicant
Medtronic Sofamor Danek USA, Inc.
510(k) number
K254165
Product code
NKG
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-21
Date received
2025-12-22
Regulation
888.3075
Classification name
Posterior Cervical Screw System
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Wafa Mustafa
Address
1800 Pyramid Pl. Memphis TN US 38132 38132

FDA Registration Numbers

Source Documents

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

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
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
K231654NorthStar OCT SystemSeaspine, Inc.2023-08-03