SteriTrak
Arbutus Medical Inc.
ARBUTUS MEDICAL, INC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013004243 | 3013004243 | ARBUTUS MEDICAL, INC | 1 | N | 2026-01-01 | 2520 Columbia St Vancouver British Columbia CA V5Y 3E9 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 194013 | 2008398333 | K203605 | SteriTrak | JEC | 2021-04-23 |
| 194013 | 1287759423 | ||||
| 194013 | 1445688910 | ||||
| 194013 | 1785981642 | ||||
| 194013 | 1808246380 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JEC | 1 | 2021-04-23 |
PMN#
GUDID#
Arbutus Medical - The TrakPak surgical kit is intended to provide general medical devices and an antiseptic skin swab for the purpose of skeletal traction for a patient with a broken pelvis or lower limb.
2026-06-22
Arbutus Medical - The TrakPak surgical kit is intended to provide general medical devices and an antiseptic skin swab for the purpose of skeletal traction for a patient with a broken pelvis or lower limb.
2026-06-22
Arbutus Medical - The TrakPak surgical kit is intended to provide general medical devices and an antiseptic skin swab for the purpose of skeletal traction for a patient with a broken pelvis or lower limb.
2026-06-22
Arbutus Medical - The TrakPak surgical kit is intended to provide general medical devices and an antiseptic skin swab for the purpose of skeletal traction for a patient with a broken pelvis or lower limb.
2026-06-22
Arbutus Medical - The TrakPak surgical kit is intended to provide general medical devices and an antiseptic skin swab for the purpose of skeletal traction for a patient with a broken pelvis or lower limb.
2026-06-22
Arbutus Medical - The TrakPak surgical kit is intended to provide general medical devices and an antiseptic skin swab for the purpose of skeletal traction for a patient with a broken pelvis or lower limb.
2026-06-22
Arbutus Medical - The TrakPak surgical kit is intended to provide general medical devices and an antiseptic skin swab for the purpose of skeletal traction for a patient with a broken pelvis or lower limb.
2026-04-28
Arbutus Medical - The TrakPak surgical kit is intended to provide general medical devices and an antiseptic skin swab for the purpose of skeletal traction for a patient with a broken pelvis or lower limb.
2026-04-28
Arbutus Medical - The TrakPak surgical kit is intended to provide general medical devices and an antiseptic skin swab for the purpose of skeletal traction for a patient with a broken pelvis or lower limb.
2026-04-28
QuikBow - QuikBow® is a pin tensioner applied to tension a 2mm k-wire during skeletal traction procedures.
2026-04-28
Arbutus Medical - Digit Revision SwiftKit is a surgical procedure kit for digit revision amputations, nail bed repair, or debridement procedures.
2026-04-28
Arbutus Medical - SteriTrak is a sterile, temporarily implantable Kirschner wire (K-wire) intended to be implanted into any bone for the purposes of providing an anchor for skeletal traction.
2021-10-19
Arbutus Medical - Rechargeable battery-powered surgical power tool drill, non-sterile.
2021-10-19
Arbutus Medical - The TrakPak surgical kit is intended to provide general medical devices and an antiseptic skin swab for the purpose of skeletal traction for a patient with a broken pelvis or lower limb.
2021-10-19
Arbutus Medical - The TrakPak surgical kit is intended to provide general medical devices and an antiseptic skin swab for the purpose of skeletal traction for a patient with a broken pelvis or lower limb.
2021-10-19