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FDA 510(k)

Gibralt® Spine System and Gibralt® Occipital Spine System

K-Number: K160697 · 2016-06-28

ApplicantExactech, Inc.
Decision Date2016-06-28
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Gibralt® Spine System and Gibralt® Occipital Spine System is a medical device manufactured by Exactech, Inc.. It received FDA 510(k) clearance on 2016-06-28 under approval number K160697. 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 Gibralt® Spine System and Gibralt® Occipital Spine System?

Gibralt® Spine System and Gibralt® Occipital Spine System is a medical device that received FDA 510(k) clearance on 2016-06-28. It is manufactured by Exactech, Inc.. The 510(k) number is K160697.

When was Gibralt® Spine System and Gibralt® Occipital Spine System approved by the FDA?

Gibralt® Spine System and Gibralt® Occipital Spine System received FDA 510(k) clearance on 2016-06-28, under approval number K160697.

What company makes Gibralt® Spine System and Gibralt® Occipital Spine System?

Gibralt® Spine System and Gibralt® Occipital Spine System is manufactured by Exactech, Inc..

What is the FDA product code for Gibralt® Spine System and Gibralt® Occipital Spine System?

The FDA product code for Gibralt® Spine System and Gibralt® Occipital Spine System is NKG.

Related Clinical Trials

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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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