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FDA 510(k)

MectaScope System

K-Number: K200067 · 2020-10-01

ApplicantMedacta International S.A.
Decision Date2020-10-01
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MectaScope 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 2020-10-01 under 510(k) number K200067. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MectaScope System?

MectaScope System is a medical device that received FDA 510(k) clearance on 2020-10-01. The listed applicant is Medacta International S.A.. The 510(k) number is K200067.

When did MectaScope System receive FDA 510(k) clearance?

MectaScope System received FDA 510(k) clearance on 2020-10-01, under 510(k) number K200067.

Who is the listed applicant for MectaScope 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 MectaScope System?

The FDA product code for MectaScope System is HRX.

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Related Devices (Code: HRX)

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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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