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FDA 510(k)

Nexo-Gide Bilayer Collagen Membrane

K-Number: K203496 · 2021-07-14

Decision Date2021-07-14
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Nexo-Gide Bilayer Collagen Membrane is a medical device manufactured by Geistlich Pharma AG. It received FDA 510(k) clearance on 2021-07-14 under approval number K203496. 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 Nexo-Gide Bilayer Collagen Membrane?

Nexo-Gide Bilayer Collagen Membrane is a medical device that received FDA 510(k) clearance on 2021-07-14. It is manufactured by Geistlich Pharma AG. The 510(k) number is K203496.

When was Nexo-Gide Bilayer Collagen Membrane approved by the FDA?

Nexo-Gide Bilayer Collagen Membrane received FDA 510(k) clearance on 2021-07-14, under approval number K203496.

What company makes Nexo-Gide Bilayer Collagen Membrane?

Nexo-Gide Bilayer Collagen Membrane is manufactured by Geistlich Pharma AG.

What is the FDA product code for Nexo-Gide Bilayer Collagen Membrane?

The FDA product code for Nexo-Gide Bilayer Collagen Membrane is FTM.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.