510(k) K170539 ยท KNW Instrument, Biopsy
Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm
| Applicant | Avitus Orthopaedics, Inc., Farmington CT, US |
| Decision | Substantially Equivalent, Mar 20, 2017 |
| Received | Feb 23, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K170539
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 18, 2019 | Avitus Orthopaedics, Inc. Avitus Bone Harvester w/ Filter Insert - 5mm
intended to harvest cancellous bone and bone marrow
Catalog Number: BH-210
The Avitus Bone Harvester is intended to harvest cancellous bone and bone marr Terminated |
KNW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.