Data / Medical devices / Canada / Arbutus Medical, Inc
Arbutus Medical, Inc: FDA-registered device maker in Burnaby British Columbia, Canada, 1 510(k) clearance
Arbutus Medical, Inc is registered with the FDA (registration 3013004243) in Burnaby British Columbia, Canada. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 23, 2021. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3013004243
- Address
- #535 & 540 - 3625 Brighton Ave, Burnaby British Columbia, Canada, V5A 3H5
- Owner or operator
- Arbutus Medical, Inc (10051759)
- Roles
- Manufacturer
- First device listed
- April 29, 2016
- Registered through
- 2026
- Brand names listed
- Digit Revision SwiftKit, DrillCover Hex System, DrillCover PRO System, Foot Debridement SwiftKit, Nailbed Repair SwiftKit, QuikBow, SawCover System, Skeletal Traction Procedure Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Component, Traction, Invasive | JEC | 2 | Manufacturer | accessdata.fda.gov |
| Component, Traction, Non-Invasive | KQZ | 1 | Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | 1 | Manufacturer | accessdata.fda.gov |
| Minor Surgical Procedures Tray | PYB | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 23, 2021 | K203605 | SteriTrak | JEC | Substantially Equivalent | Arbutus Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- All makers of Minor Surgical Procedures Tray
- All makers of Component, Traction, Invasive
- All makers of Drape, Surgical, Exempt
- All makers of Component, Traction, Non-Invasive
Updated April 23, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.