Company ยท US
Aziyo Biologics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2020. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FTM | Mesh, Surgical | 6 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 15, 2020 | K201313 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGa Aziyo Biologics, Inc. | FTM |
| Oct 21, 2019 | K192616 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGa Aziyo Biologics, Inc. | FTM |
| Nov 15, 2018 | K182255 | CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro En Aziyo Biologics, Inc. | FTM |
| Oct 25, 2017 | K173242 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large) Aziyo Biologics, Inc. | FTM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 21, 2019 | AZIYO BIOLOGICS CanGaroo Envelopes labeled as the following:
1. CanGaroo Envelope (Large) (single pack);
2. CanGaroo Envelope (Medium) (single pack);
3. CanGaroo Envelope (Extra Large) (single pack);
4. C Terminated |
FTM | K140306 K173242 +1 |
| Aug 21, 2019 | AZIYO BIOLOGICS BioEnvelope, surgical mesh envelope. Labeled as the following:
1. BioEnvelope (Medium) (single pack);
2. BioEnvelope (Large) (single pack);
3. BioEnvelope (Extra Large) (single pack);
4. Terminated |
FTM | K140306 |