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FDA 510(k)

M-ARS ACL: Anatomic Ribbon Surgery System

K-Number: K171640 · 2017-10-23

Decision Date2017-10-23
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

M-ARS ACL: Anatomic Ribbon Surgery System is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2017-10-23 under approval number K171640. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the M-ARS ACL: Anatomic Ribbon Surgery System?

M-ARS ACL: Anatomic Ribbon Surgery System is a medical device that received FDA 510(k) clearance on 2017-10-23. It is manufactured by Medacta International S.A.. The 510(k) number is K171640.

When was M-ARS ACL: Anatomic Ribbon Surgery System approved by the FDA?

M-ARS ACL: Anatomic Ribbon Surgery System received FDA 510(k) clearance on 2017-10-23, under approval number K171640.

What company makes M-ARS ACL: Anatomic Ribbon Surgery System?

M-ARS ACL: Anatomic Ribbon Surgery System is manufactured by Medacta International S.A..

What is the FDA product code for M-ARS ACL: Anatomic Ribbon Surgery System?

The FDA product code for M-ARS ACL: Anatomic Ribbon Surgery System is MBI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.