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FDA 510(k)

Nexo-Gide Bilayer Collagen Membrane

K-Number: K203496 · 2021-07-14

ApplicantGeistlich Pharma AG
Decision Date2021-07-14
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Nexo-Gide Bilayer Collagen Membrane is the device name listed in this FDA 510(k) record. The listed applicant is Geistlich Pharma AG. It received FDA 510(k) clearance on 2021-07-14 under 510(k) 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. The listed applicant is Geistlich Pharma AG. The 510(k) number is K203496.

When did Nexo-Gide Bilayer Collagen Membrane receive FDA 510(k) clearance?

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

Who is the listed applicant for Nexo-Gide Bilayer Collagen Membrane?

The FDA 510(k) record lists Geistlich Pharma AG as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Geistlich Pharma AG as applicant

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Related Devices (Code: FTM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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