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FDA 510(k)

Tiger® Occipital-Cervical-Thoracic Spinal Fixation System

K-Number: K200863 · 2020-04-28

ApplicantCorelink, LLC
Decision Date2020-04-28
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tiger® Occipital-Cervical-Thoracic Spinal Fixation System is a medical device manufactured by Corelink, LLC. It received FDA 510(k) clearance on 2020-04-28 under approval number K200863. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tiger® Occipital-Cervical-Thoracic Spinal Fixation System?

Tiger® Occipital-Cervical-Thoracic Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2020-04-28. It is manufactured by Corelink, LLC. The 510(k) number is K200863.

When was Tiger® Occipital-Cervical-Thoracic Spinal Fixation System approved by the FDA?

Tiger® Occipital-Cervical-Thoracic Spinal Fixation System received FDA 510(k) clearance on 2020-04-28, under approval number K200863.

What company makes Tiger® Occipital-Cervical-Thoracic Spinal Fixation System?

Tiger® Occipital-Cervical-Thoracic Spinal Fixation System is manufactured by Corelink, LLC.

What is the FDA product code for Tiger® Occipital-Cervical-Thoracic Spinal Fixation System?

The FDA product code for Tiger® Occipital-Cervical-Thoracic Spinal Fixation System is NKG.

Related Clinical Trials

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Corelink, LLC

K152237The Entasis Dual-Lead Sacroiliac Implant K163104Terrace™ Anterior Cervical Plate System K162496Foundation 3D Interbody K183239CoreLink F3D™ Lateral System K180814CoreLink® M3™ Stand-Alone Anterior Lumbar System K180556Corelink Foundation 3D Anterior Lumbar System

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Related Devices (Code: NKG)

K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG K162300Reform® POCT SystemPrecision Spine, Inc. K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. K161478Xenco Medical Posterior Cervical SystemXenco Medical, LLC K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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