Home / 510(k) Clearances / K981423

510(k) K981423

AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000 by Autogenesis, Inc. — Product Code JEC

K981423 is an FDA 510(k) premarket notification submitted by Autogenesis, Inc. for the device "AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000". The FDA issued a decision of Substantially Equivalent on May 20, 1998. The device falls under product code JEC (Component, Traction, Invasive), a Class II device regulated under 21 CFR 888.3040. Autogenesis, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1998
Date Received
April 20, 1998
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 by Autogenesis, Inc.

  • K013818 — AUTOGENESIS AUTOMATOR, MODEL M1000 (December 5, 2001)

Other clearances for product code JEC

  • K203605 — SteriTrak (April 23, 2021)
  • K193256 — Anjon Bremer Halo System (March 2, 2020)
  • 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)

FDA data resources