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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 the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2019-04-10 under 510(k) 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. The listed applicant is Medacta International S.A.. The 510(k) number is K190631.

When did M.U.S.T. MINI Posterior Cervical Screws System receive FDA 510(k) clearance?

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

Who is the listed applicant for M.U.S.T. MINI Posterior Cervical Screws System?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

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.

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Related Devices (Code: NKG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AGK253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.

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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