Nexo-Gide Bilayer Collagen Membrane
FDA 510(k) K203496 · Geistlich Pharma AG
510(k) numberK203496
Submission
- Device name
- Nexo-Gide Bilayer Collagen Membrane
- Applicant
- Geistlich Pharma AG
Wolhusen, CH - Received
- November 27, 2020
- Decision date
- July 14, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTM – Mesh, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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Questions and answers
When was Nexo-Gide Bilayer Collagen Membrane cleared by the FDA?
Nexo-Gide Bilayer Collagen Membrane (K203496) received a 510(k) decision of Substantially Equivalent on July 14, 2021, 229 days after the submission was received.
What is the product code of K203496?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.