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510(k) K203605

SteriTrak by Arbutus Medical, Inc. — Product Code JEC

K203605 is an FDA 510(k) premarket notification submitted by Arbutus Medical, Inc. for the device "SteriTrak". The FDA issued a decision of Substantially Equivalent on April 23, 2021. The device falls under product code JEC (Component, Traction, Invasive), a Class II device regulated under 21 CFR 888.3040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2021
Date Received
December 10, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, Traction, Invasive
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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  • K181192 — PIP Fix (October 22, 2018)
  • K171863 — Anjon Bremer Halo System (March 19, 2018)
  • K163028 — Medline ReNewal Reprocessed Stryker External Fixation Devices (December 28, 2016)
  • K132731 — DIGIFIX EXTERNAL FIXATION SYSTEM (January 10, 2014)
  • K102885 — HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020 (January 14, 2011)
  • K082679 — LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X (April 7, 2009)
  • K072432 — F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE (January 9, 2008)
  • K071476 — SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP (August 24, 2007)

FDA data resources