Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aziyo Biologics, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201313 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGa | Aziyo Biologics, Inc. | 2020-06-15 | 28 | 0 |
| K192616 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGa | Aziyo Biologics, Inc. | 2019-10-21 | 28 | 0 |
| K182255 | CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (m | Aziyo Biologics, Inc. | 2018-11-15 | 87 | 0 |
| K173242 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGa | Aziyo Biologics, Inc. | 2017-10-25 | 19 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda