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FDA 510(k)

G Surgical OCT Spinal System

K-Number: K171834 · 2017-12-19

ApplicantG Surgical, LLC
Decision Date2017-12-19
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

G Surgical OCT Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is G Surgical, LLC. It received FDA 510(k) clearance on 2017-12-19 under 510(k) number K171834. 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 G Surgical OCT Spinal System?

G Surgical OCT Spinal System is a medical device that received FDA 510(k) clearance on 2017-12-19. The listed applicant is G Surgical, LLC. The 510(k) number is K171834.

When did G Surgical OCT Spinal System receive FDA 510(k) clearance?

G Surgical OCT Spinal System received FDA 510(k) clearance on 2017-12-19, under 510(k) number K171834.

Who is the listed applicant for G Surgical OCT Spinal System?

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

What is the FDA product code for G Surgical OCT Spinal System?

The FDA product code for G Surgical OCT Spinal System is NKG.

Other records listing G Surgical, LLC as applicant

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.

K240737G Surgical Marksman MIS SystemK230063G Surgical Marksman Spinal Deformity SystemK210890GPS Cervical SpacersK193219G Surgical Marksman SystemK161516G Surgical Marksman MIS System

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

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

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