# Aziyo Biologics, Inc.

- Location (FDA's records): Roswell, GA
- FDA decisions: 4 (2017–2020): 4 510(k) clearances
- Product codes: FTM (4)
- 510(k) review time since 2016: median 28 days, against 107 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 4 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cormatrix Cardiovascular, Inc.: 1 (https://510kreport.com/company/cormatrix-cardiovascular)

## Its most-cited devices
- K192616: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ) (2019), cited by 1
- K182255: CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) (2018), cited by 1
- K173242: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large) (2017), cited by 1

## Recent decisions
- K201313: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) (Jun 15, 2020)
- K192616: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ) (Oct 21, 2019)
- K182255: CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large) (Nov 15, 2018)
- K173242: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large) (Oct 25, 2017)

Source page: https://510kreport.com/company/aziyo-biologics