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FDA 510(k)

M.U.S.T. MINI Posterior Cervical Screws System

K-Number: K190631 · 2019-04-10

ApplicantMedacta International S.A.
Decision Date2019-04-10
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

M.U.S.T. MINI Posterior Cervical Screws System is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2019-04-10 under approval number K190631. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M.U.S.T. MINI Posterior Cervical Screws System?

M.U.S.T. MINI Posterior Cervical Screws System is a medical device that received FDA 510(k) clearance on 2019-04-10. It is manufactured by Medacta International S.A.. The 510(k) number is K190631.

When was M.U.S.T. MINI Posterior Cervical Screws System approved by the FDA?

M.U.S.T. MINI Posterior Cervical Screws System received FDA 510(k) clearance on 2019-04-10, under approval number K190631.

What company makes M.U.S.T. MINI Posterior Cervical Screws System?

M.U.S.T. MINI Posterior Cervical Screws System is manufactured by Medacta International S.A..

What is the FDA product code for M.U.S.T. MINI Posterior Cervical Screws System?

The FDA product code for M.U.S.T. MINI Posterior Cervical Screws System is NKG.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING

Other Devices by Medacta International S.A.

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Related Devices (Code: NKG)

K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG K162300Reform® POCT SystemPrecision Spine, Inc. K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. K161478Xenco Medical Posterior Cervical SystemXenco Medical, LLC K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, 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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