Endoform Reconstructive Template
K-Number: K153633 · 2016-03-15
Decision Date2016-03-15
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Endoform Reconstructive Template is a medical device manufactured by Aroa Biosurgery Limited (Formerly Mesynthes Limited). It received FDA 510(k) clearance on 2016-03-15 under approval number K153633. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Endoform Reconstructive Template?
Endoform Reconstructive Template is a medical device that received FDA 510(k) clearance on 2016-03-15. It is manufactured by Aroa Biosurgery Limited (Formerly Mesynthes Limited). The 510(k) number is K153633.
When was Endoform Reconstructive Template approved by the FDA?
Endoform Reconstructive Template received FDA 510(k) clearance on 2016-03-15, under approval number K153633.
What company makes Endoform Reconstructive Template?
Endoform Reconstructive Template is manufactured by Aroa Biosurgery Limited (Formerly Mesynthes Limited).
What is the FDA product code for Endoform Reconstructive Template?
The FDA product code for Endoform Reconstructive Template is FTM.
Other Devices by Aroa Biosurgery Limited (Formerly Mesynthes Limited)
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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.