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FDA 510(k)

GMA 2.0 Pedicle Screw System

K-Number: K192915 · 2019-11-13

ApplicantGrafton Medical Alliance
Decision Date2019-11-13
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GMA 2.0 Pedicle Screw System is a medical device manufactured by Grafton Medical Alliance. It received FDA 510(k) clearance on 2019-11-13 under approval number K192915. 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 GMA 2.0 Pedicle Screw System?

GMA 2.0 Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2019-11-13. It is manufactured by Grafton Medical Alliance. The 510(k) number is K192915.

When was GMA 2.0 Pedicle Screw System approved by the FDA?

GMA 2.0 Pedicle Screw System received FDA 510(k) clearance on 2019-11-13, under approval number K192915.

What company makes GMA 2.0 Pedicle Screw System?

GMA 2.0 Pedicle Screw System is manufactured by Grafton Medical Alliance.

What is the FDA product code for GMA 2.0 Pedicle Screw System?

The FDA product code for GMA 2.0 Pedicle Screw System is NKB.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT06720948 The ION Facet Screw System Ambispective Evaluation ENROLLING_BY_INVITATION NCT06960018 Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement RECRUITING

Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 37209414 Adverse events associated with Aveir Journal of cardiovascular electrophysiology (2023) PMID: 30035086 Translational research of one dynamic hip screw system-from the SCI to the FDA. Journal of orthopaedic translation (2016)

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.

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