FDA.report

510(k) K231654

Device
NorthStar OCT System
Applicant
Seaspine, Inc.
510(k) number
K231654
Product code
NKG
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-03
Date received
2023-06-06
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
Jesse Albright
Address
5770 Armada Dr. Carlsbad CA US 92008 92008

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
10889981196622NorthStarSeaspine Orthopedics Corporation2025-12-19
10889981260132NorthStarSeaspine Orthopedics Corporation2025-12-19
10889981200008NorthStarSeaspine Orthopedics Corporation2025-12-19
10889981196684NorthStarSeaspine Orthopedics Corporation2025-12-19
10889981196660NorthStarSeaspine Orthopedics Corporation2025-12-19
10889981196677NorthStarSeaspine Orthopedics Corporation2025-12-19
10889981196615NorthStarSeaspine Orthopedics Corporation2025-12-19
10889981196639NorthStarSeaspine Orthopedics Corporation2025-12-19
10889981320720NorthStarSEASPINE ORTHOPEDICS CORPORATION2023-12-06
10889981320898NorthStarSEASPINE ORTHOPEDICS CORPORATION2023-12-06
10889981320614NorthStarSEASPINE ORTHOPEDICS CORPORATION2023-12-06
10889981320621NorthStarSEASPINE ORTHOPEDICS CORPORATION2023-12-06
10889981320638NorthStarSEASPINE ORTHOPEDICS CORPORATION2023-12-06
10889981320645NorthStarSEASPINE ORTHOPEDICS CORPORATION2023-12-06
10889981320652NorthStarSEASPINE ORTHOPEDICS CORPORATION2023-12-06
10889981320669NorthStarSEASPINE ORTHOPEDICS CORPORATION2023-12-06
10889981320676NorthStarSEASPINE ORTHOPEDICS CORPORATION2023-12-06
10889981320683NorthStarSEASPINE ORTHOPEDICS CORPORATION2023-12-06
10889981320881NorthStarSEASPINE ORTHOPEDICS CORPORATION2023-12-06
10889981320706NorthStarSEASPINE ORTHOPEDICS CORPORATION2023-12-06
10889981320713NorthStarSEASPINE ORTHOPEDICS CORPORATION2023-12-06
10889981320737NorthStarSEASPINE ORTHOPEDICS CORPORATION2023-12-06
10889981320867NorthStarSEASPINE ORTHOPEDICS CORPORATION2023-12-06
10889981320768NorthStarSEASPINE ORTHOPEDICS CORPORATION2023-12-06
10889981320775NorthStarSEASPINE ORTHOPEDICS CORPORATION2023-12-06
10889981320782NorthStarSEASPINE ORTHOPEDICS CORPORATION2023-12-06
10889981320799NorthStarSEASPINE ORTHOPEDICS CORPORATION2023-12-06
10889981320805NorthStarSEASPINE ORTHOPEDICS CORPORATION2023-12-06
10889981320850NorthStarSEASPINE ORTHOPEDICS CORPORATION2023-12-06
10889981320829NorthStarSEASPINE ORTHOPEDICS CORPORATION2023-12-06

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
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