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FDA 510(k)

Innovasis Gibralt Spine System

K-Number: K192354 · 2019-09-24

ApplicantInnovasis, Inc.
Decision Date2019-09-24
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Innovasis Gibralt Spine System is a medical device manufactured by Innovasis, Inc.. It received FDA 510(k) clearance on 2019-09-24 under approval number K192354. 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 Innovasis Gibralt Spine System?

Innovasis Gibralt Spine System is a medical device that received FDA 510(k) clearance on 2019-09-24. It is manufactured by Innovasis, Inc.. The 510(k) number is K192354.

When was Innovasis Gibralt Spine System approved by the FDA?

Innovasis Gibralt Spine System received FDA 510(k) clearance on 2019-09-24, under approval number K192354.

What company makes Innovasis Gibralt Spine System?

Innovasis Gibralt Spine System is manufactured by Innovasis, Inc..

What is the FDA product code for Innovasis Gibralt Spine System?

The FDA product code for Innovasis Gibralt Spine System is NKG.

Related Clinical Trials

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Related PubMed Literature

PMID: 36074993 Reported Events Associated With Spine Robots: An Analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database. Global spine journal (2023)

Other Devices by Innovasis, Inc.

K162143FixxSure® X-Link K162236Ax Stand-Alone ALIF System K181115CxHA PEEK Cervical IBF System K181063Kestrel™ Buttress Plate System K180078Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System K192049Oryx Cervical Plate 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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