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510(k) K192465

DigiFix Sterile Kit by Virak Orthopedics, LLC — Product Code JEC

K192465 is an FDA 510(k) premarket notification submitted by Virak Orthopedics, LLC for the device "DigiFix Sterile Kit". The FDA issued a decision of Substantially Equivalent on October 10, 2019. 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
October 10, 2019
Date Received
September 9, 2019
Clearance Type
Special
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

Other clearances for product code JEC

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  • K193256 — Anjon Bremer Halo System (March 2, 2020)
  • 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