FDA 510(k)

SteriTrak

K-Number: K203605 · 2021-04-23

Decision Date2021-04-23

Product CodeJEC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SteriTrak is the device name listed in this FDA 510(k) record. The listed applicant is Arbutus Medical, Inc.. It received FDA 510(k) clearance on 2021-04-23 under 510(k) number K203605. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SteriTrak?

SteriTrak is a medical device that received FDA 510(k) clearance on 2021-04-23. The listed applicant is Arbutus Medical, Inc.. The 510(k) number is K203605.

When did SteriTrak receive FDA 510(k) clearance?

SteriTrak received FDA 510(k) clearance on 2021-04-23, under 510(k) number K203605.

Who is the listed applicant for SteriTrak?

The FDA 510(k) record lists Arbutus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SteriTrak?

The FDA product code for SteriTrak is JEC.

Related Devices (Code: JEC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193256Anjon Bremer Halo SystemAnjon Holdings, LLC K192465DigiFix Sterile KitVirak Orthopedics, LLC K181192PIP FixHand Biomechanics Lab, Inc.K171863Anjon Bremer Halo SystemAnjon Holdings, LLC K163028Medline ReNewal Reprocessed Stryker External Fixation DevicesSurgical Instrument Service and Savings, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.