FDA 510(k)

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

K-Number: K203671 · 2021-01-13

Decision Date2021-01-13

Product CodeOUR

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

M.U.S.T. Sacral Iliac 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 2021-01-13 under 510(k) number K203671. 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 Iliac Screw and Pelvic Trauma System?

M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System is a medical device that received FDA 510(k) clearance on 2021-01-13. The listed applicant is Medacta International S.A.. The 510(k) number is K203671.

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

M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System received FDA 510(k) clearance on 2021-01-13, under 510(k) number K203671.

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

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

Other records listing Medacta International S.A. as applicant

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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.