# K203496: Nexo-Gide Bilayer Collagen Membrane

- Pathway: 510(k) (Traditional)
- Applicant: Geistlich Pharma AG
- Decided: Jul 14, 2021 after 229 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000019 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053655: Tendon Wrap Tendon Protector, Integra LifeSciences Corporation (2006) Summary page 5.

## Indications for use
The Nexo-Gide™ Bilayer Collagen Membrane is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Source page: https://510kreport.com/device/K203496
Methodology: https://510kreport.com/methodology