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FDA 510(k)

Goblin and Goblin LS Pedicle Screw Systems

K-Number: K210420 · 2021-04-19

ApplicantMedynus, Inc.
Decision Date2021-04-19
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Goblin and Goblin LS Pedicle Screw Systems is a medical device manufactured by Medynus, Inc.. It received FDA 510(k) clearance on 2021-04-19 under approval number K210420. 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 Goblin and Goblin LS Pedicle Screw Systems?

Goblin and Goblin LS Pedicle Screw Systems is a medical device that received FDA 510(k) clearance on 2021-04-19. It is manufactured by Medynus, Inc.. The 510(k) number is K210420.

When was Goblin and Goblin LS Pedicle Screw Systems approved by the FDA?

Goblin and Goblin LS Pedicle Screw Systems received FDA 510(k) clearance on 2021-04-19, under approval number K210420.

What company makes Goblin and Goblin LS Pedicle Screw Systems?

Goblin and Goblin LS Pedicle Screw Systems is manufactured by Medynus, Inc..

What is the FDA product code for Goblin and Goblin LS Pedicle Screw Systems?

The FDA product code for Goblin and Goblin LS Pedicle Screw Systems is NKB.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT06960018 Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement RECRUITING

Related PubMed Literature

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)

Other Devices by Medynus, Inc.

K212792Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage K220379IMPEACE and IMPEACE-Uni Anterior Cervical Plate System

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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