Mectaplug PE II
K-Number: K210062 · 2021-04-08
ApplicantMedacta International S.A.
Decision Date2021-04-08
Product CodeJDK
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Mectaplug PE II is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2021-04-08 under approval number K210062. The device is classified under product code JDK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Mectaplug PE II?
Mectaplug PE II is a medical device that received FDA 510(k) clearance on 2021-04-08. It is manufactured by Medacta International S.A.. The 510(k) number is K210062.
When was Mectaplug PE II approved by the FDA?
Mectaplug PE II received FDA 510(k) clearance on 2021-04-08, under approval number K210062.
What company makes Mectaplug PE II?
Mectaplug PE II is manufactured by Medacta International S.A..
What is the FDA product code for Mectaplug PE II?
The FDA product code for Mectaplug PE II is JDK.
Other Devices by Medacta International S.A.
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.