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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 the device name listed in this FDA 510(k) record. The listed applicant is Corelink, LLC. It received FDA 510(k) clearance on 2020-04-28 under 510(k) 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. The listed applicant is Corelink, LLC. The 510(k) number is K200863.

When did Tiger® Occipital-Cervical-Thoracic Spinal Fixation System receive FDA 510(k) clearance?

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

Who is the listed applicant for Tiger® Occipital-Cervical-Thoracic Spinal Fixation System?

The FDA 510(k) record lists Corelink, LLC as the applicant. This does not by itself establish the device manufacturer.

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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Other records listing Corelink, LLC as applicant

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Related Devices (Code: NKG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AGK253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.

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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