Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013004243

FEI Number

3013004243

Entity Name

ARBUTUS MEDICAL, INC

City/State/Country

Vancouver British Columbia, CA

Establishment Address

2520 Columbia St, Vancouver British Columbia V5Y 3E9, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Arbutus Medical, Inc (Owner Number: 10051759)

Owner / Operator Contact Address

2520 Columbia St., Vancouver, CA-BC V5Y 3E9, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203605

PMA Number

N/A

All Registered Proprietary Names

QuikBow SteriTrak System TrakPak Skeletal Traction Procedure Kit Foot Debridement SwiftKit Digit Revision SwiftKit Nailbed Repair SwiftKit DrillCover Hex System SawCover System DrillCover PRO System SteriTrak Drill

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2023-01-23
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2021-08-09
PYB	Minor Surgical Procedures Tray	General, Plastic Surgery	Class 1	878.4800	2021-03-08
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2016-04-29
JEC	Component, Traction, Invasive	Orthopedic	Class 2	888.3040	2021-08-09

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Arbutus Medical, Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013004243. Last updated year: 2026. Please use registration number 3013004243 when referencing this establishment in official correspondence.