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FDA 510(k)

M.U.S.T. Pedicle Screw Extension and Long Tab Implants

K-Number: K203482 · 2021-01-26

ApplicantMedacta International S.A.
Decision Date2021-01-26
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

M.U.S.T. Pedicle Screw Extension and Long Tab Implants is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2021-01-26 under approval number K203482. 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 M.U.S.T. Pedicle Screw Extension and Long Tab Implants?

M.U.S.T. Pedicle Screw Extension and Long Tab Implants is a medical device that received FDA 510(k) clearance on 2021-01-26. It is manufactured by Medacta International S.A.. The 510(k) number is K203482.

When was M.U.S.T. Pedicle Screw Extension and Long Tab Implants approved by the FDA?

M.U.S.T. Pedicle Screw Extension and Long Tab Implants received FDA 510(k) clearance on 2021-01-26, under approval number K203482.

What company makes M.U.S.T. Pedicle Screw Extension and Long Tab Implants?

M.U.S.T. Pedicle Screw Extension and Long Tab Implants is manufactured by Medacta International S.A..

What is the FDA product code for M.U.S.T. Pedicle Screw Extension and Long Tab Implants?

The FDA product code for M.U.S.T. Pedicle Screw Extension and Long Tab Implants is NKB.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05729620 Evaluation of STARgraft-3 for Hemodialysis ACTIVE_NOT_RECRUITING NCT06941558 The UK ADAPTIS Study ACTIVE_NOT_RECRUITING NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT04695899 Zirconia Implants for Replacement of a Single Tooth ACTIVE_NOT_RECRUITING 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)

Other Devices by Medacta International S.A.

K163311GMK Revision Femoral Distal Augmentation K162061M.U.S.T. Pedicle Screw System K153273MySpine Pedicle Screw Placement Guides - LP K171058Medacta Shoulder System: Threaded Glenoid Baseplate K173267MasterLoc Stem: Lateralized Plus K170690M-Vizion Femoral Revision System

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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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