Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

M.U.S.T. Mini Extension

K-Number: K182837 · 2019-01-22

ApplicantMedacta International S.A.
Decision Date2019-01-22
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

M.U.S.T. Mini Extension 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 2019-01-22 under 510(k) number K182837. 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 Extension?

M.U.S.T. Mini Extension is a medical device that received FDA 510(k) clearance on 2019-01-22. The listed applicant is Medacta International S.A.. The 510(k) number is K182837.

When did M.U.S.T. Mini Extension receive FDA 510(k) clearance?

M.U.S.T. Mini Extension received FDA 510(k) clearance on 2019-01-22, under 510(k) number K182837.

Who is the listed applicant for M.U.S.T. Mini Extension?

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 Extension?

The FDA product code for M.U.S.T. Mini Extension is NKG.

Other records listing Medacta International S.A. as applicant

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.

K254202MectaLIF 3D Metal AnteriorK253940M.U.S.T. Pedicle Screw System - ExtensionK253328GMK 3D Metal Tibial Tray ExtensionK250644MSS - Monobloc stemK251043Mpact 3D Metal Implants Extension – DMLS TechnologyK252847NextAR Hip Platform

View all 146 devices →

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.

↑