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FDA 510(k)

M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System

K-Number: K193083 · 2019-12-03

ApplicantMedacta International S.A.
Decision Date2019-12-03
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

M.U.S.T. Sacral Illiac Screw and Pelvic Trauma 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 2019-12-03 under 510(k) number K193083. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System?

M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System is a medical device that received FDA 510(k) clearance on 2019-12-03. The listed applicant is Medacta International S.A.. The 510(k) number is K193083.

When did M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System receive FDA 510(k) clearance?

M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System received FDA 510(k) clearance on 2019-12-03, under 510(k) number K193083.

Who is the listed applicant for M.U.S.T. Sacral Illiac Screw and Pelvic Trauma 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. Sacral Illiac Screw and Pelvic Trauma System?

The FDA product code for M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System is OUR.

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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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