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 a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2020-10-01 under approval 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. It is manufactured by Medacta International S.A.. The 510(k) number is K200067.
When was MectaScope System approved by the FDA?
MectaScope System received FDA 510(k) clearance on 2020-10-01, under approval number K200067.
What company makes MectaScope System?
MectaScope System is manufactured by Medacta International S.A..
What is the FDA product code for MectaScope System?
The FDA product code for MectaScope System is 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.