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FDA 510(k)

M-ARS ACL: Anatomic Ribbon Surgery System

K-Number: K171640 · 2017-10-23

ApplicantMedacta International S.A.
Decision Date2017-10-23
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

M-ARS ACL: Anatomic Ribbon Surgery 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 2017-10-23 under 510(k) 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. The listed applicant is Medacta International S.A.. The 510(k) number is K171640.

When did M-ARS ACL: Anatomic Ribbon Surgery System receive FDA 510(k) clearance?

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

Who is the listed applicant for M-ARS ACL: Anatomic Ribbon Surgery 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-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

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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