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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 the device name listed in this FDA 510(k) record. The listed applicant is Innovasis, Inc.. It received FDA 510(k) clearance on 2019-09-24 under 510(k) 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. The listed applicant is Innovasis, Inc.. The 510(k) number is K192354.

When did Innovasis Gibralt Spine System receive FDA 510(k) clearance?

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

Who is the listed applicant for Innovasis Gibralt Spine System?

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

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

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

Other records listing Innovasis, Inc. 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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