Search Results
Found 1 results
510(k) Data Aggregation
K Number
K203605Device Name
SteriTrak
Manufacturer
Arbutus Medical Inc.
Date Cleared
2021-04-23
(134 days)
Product Code
JEC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Arbutus Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SteriTrak is indicated for implantation through the skin and bone so that traction may be applied to the skeletal system.
Device Description
SteriTrak™ is a sterile, temporarily implantable Kirschner wire (K-wire). SteriTrak™ is intended to be implanted into the bone for the purposes of providing an anchor for skeletal traction. SteriTrak™ is intended to be inserted while the patient is in the Emergency Room, prior to admittance to the Operating Room for surgery. When the patient is transferred to the Operating Room for surgery, skeletal traction is released and SteriTrak™ is removed.
The SteriTrak™ surgical grade 316L stainless steel pin is implantable up to 30 days. SteriTrak™ is provided with a guiding handle intended to be used as a pin stabilizing holder for the orthopedic surgeon.
Ask a Question
Page 1 of 1