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FDA 510(k)

M.U.S.T. Midline Cortical (MC) Screw System

K-Number: K210427 · 2021-04-20

ApplicantMedacta International S.A.
Decision Date2021-04-20
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

M.U.S.T. Midline Cortical (MC) Screw 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 2021-04-20 under 510(k) number K210427. 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. Midline Cortical (MC) Screw System?

M.U.S.T. Midline Cortical (MC) Screw System is a medical device that received FDA 510(k) clearance on 2021-04-20. The listed applicant is Medacta International S.A.. The 510(k) number is K210427.

When did M.U.S.T. Midline Cortical (MC) Screw System receive FDA 510(k) clearance?

M.U.S.T. Midline Cortical (MC) Screw System received FDA 510(k) clearance on 2021-04-20, under 510(k) number K210427.

Who is the listed applicant for M.U.S.T. Midline Cortical (MC) Screw 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. Midline Cortical (MC) Screw System?

The FDA product code for M.U.S.T. Midline Cortical (MC) Screw System is NKB.

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Related Devices (Code: NKB)

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.

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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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