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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 a medical device manufactured by G Surgical, LLC. It received FDA 510(k) clearance on 2017-12-19 under approval 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. It is manufactured by G Surgical, LLC. The 510(k) number is K171834.

When was G Surgical OCT Spinal System approved by the FDA?

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

What company makes G Surgical OCT Spinal System?

G Surgical OCT Spinal System is manufactured by G Surgical, LLC.

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

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

Related Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by G Surgical, LLC

K161516G Surgical Marksman MIS System K193219G Surgical Marksman System K210890GPS Cervical Spacers K230063G Surgical Marksman Spinal Deformity System K240737G Surgical Marksman MIS System

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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