Polydioxanone Surgical Scaffold
K-Number: K181094 · 2018-08-02
ApplicantLntegra Lifesciences
Decision Date2018-08-02
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Polydioxanone Surgical Scaffold is a medical device manufactured by Lntegra Lifesciences. It received FDA 510(k) clearance on 2018-08-02 under approval number K181094. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Polydioxanone Surgical Scaffold?
Polydioxanone Surgical Scaffold is a medical device that received FDA 510(k) clearance on 2018-08-02. It is manufactured by Lntegra Lifesciences. The 510(k) number is K181094.
When was Polydioxanone Surgical Scaffold approved by the FDA?
Polydioxanone Surgical Scaffold received FDA 510(k) clearance on 2018-08-02, under approval number K181094.
What company makes Polydioxanone Surgical Scaffold?
Polydioxanone Surgical Scaffold is manufactured by Lntegra Lifesciences.
What is the FDA product code for Polydioxanone Surgical Scaffold?
The FDA product code for Polydioxanone Surgical Scaffold is FTL.
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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.