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FDA 510(k)

Percusys® Plus Pedicle Screw System

K-Number: K192680 · 2019-12-18

ApplicantJoimax GmbH
Decision Date2019-12-18
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Percusys® Plus Pedicle Screw System is a medical device manufactured by Joimax GmbH. It received FDA 510(k) clearance on 2019-12-18 under approval number K192680. 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 Percusys® Plus Pedicle Screw System?

Percusys® Plus Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2019-12-18. It is manufactured by Joimax GmbH. The 510(k) number is K192680.

When was Percusys® Plus Pedicle Screw System approved by the FDA?

Percusys® Plus Pedicle Screw System received FDA 510(k) clearance on 2019-12-18, under approval number K192680.

What company makes Percusys® Plus Pedicle Screw System?

Percusys® Plus Pedicle Screw System is manufactured by Joimax GmbH.

What is the FDA product code for Percusys® Plus Pedicle Screw System?

The FDA product code for Percusys® Plus 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)

Other Devices by Joimax GmbH

K161378joimax Electrosurgical Instruments K170358joimax Endovapor 2 K192663Joimax Intracs System K203014EndoLIF Delta-Cage and DoubleWedge-Cage

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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