Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System

K-Number: K163096 · 2017-03-31

ApplicantGpc Medical Limited
Decision Date2017-03-31
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is a medical device manufactured by Gpc Medical Limited. It received FDA 510(k) clearance on 2017-03-31 under approval number K163096. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System?

GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is a medical device that received FDA 510(k) clearance on 2017-03-31. It is manufactured by Gpc Medical Limited. The 510(k) number is K163096.

When was GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System approved by the FDA?

GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System received FDA 510(k) clearance on 2017-03-31, under approval number K163096.

What company makes GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System?

GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is manufactured by Gpc Medical Limited.

What is the FDA product code for GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System?

The FDA product code for GPC BRAND Posterior, Non cervical Pedicle Screw Spinal System is NKB.

Related Clinical Trials

NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT07610850 Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 41487949 Verification, validation, and uncertainty quantification of finite element analysis results for pedicle screw assemblies under ASTM F1717 flexion and extension testing. Frontiers in bioengineering and biotechnology (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Gpc Medical Limited

K203811GPC Intraheal Intramedullary Nailing System K210198GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive

Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, 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.

↑