Avitus Orthopaedics, Inc.
Avitus Orthopaedics, Inc. appears in FDA public data with 2 recalls, 5 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1047-2019, Class II) was initiated on February 18, 2019. Its most recent 510(k) clearance was granted on July 17, 2023.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 5
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1047-2019 | Class II | Avitus¿ Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and bone marrow | February 18, 2019 |
| Z-1046-2019 | Class II | Avitus¿ Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellous bone and bone marrow | February 18, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K231456 | Avitus® DragonWing Large Volume Autograft Delivery System | July 17, 2023 |
| K230492 | Avitus® Precision Autograft Delivery System | June 26, 2023 |
| K210631 | Avitus(r) Bone Harvester | March 31, 2021 |
| K170539 | Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester w | March 20, 2017 |
| K152474 | Avitus Bone Harvester | October 23, 2015 |