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510(k) K193256

Anjon Bremer Halo System by Anjon Holdings, LLC — Product Code JEC

K193256 is an FDA 510(k) premarket notification submitted by Anjon Holdings, LLC for the device "Anjon Bremer Halo System". The FDA issued a decision of Substantially Equivalent on March 2, 2020. The device falls under product code JEC (Component, Traction, Invasive), a Class II device regulated under 21 CFR 888.3040. Anjon Holdings, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2020
Date Received
November 26, 2019
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

Other clearances by Anjon Holdings, LLC

  • K171863 — Anjon Bremer Halo System (March 19, 2018)

Other clearances for product code JEC

  • K203605 — SteriTrak (April 23, 2021)
  • K192465 — DigiFix Sterile Kit (October 10, 2019)
  • 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