Home / 510(k) Clearances / K840856

510(k) K840856

MODULAR CONSTRUCT FRAME EXTERNAL FIXA by Precision Medical Devices, Inc. — Product Code JEC

K840856 is an FDA 510(k) premarket notification submitted by Precision Medical Devices, Inc. for the device "MODULAR CONSTRUCT FRAME EXTERNAL FIXA". The FDA issued a decision of Substantially Equivalent on April 25, 1984. The device falls under product code JEC (Component, Traction, Invasive), a Class II device regulated under 21 CFR 888.3040. Precision Medical Devices, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1984
Date Received
February 24, 1984
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 Precision Medical Devices, Inc.

  • K863854 — P.M.D. INTRAMEDULLARY CEMENT RESTRICTOR PLUG (November 19, 1986)
  • K840046 — PRESSURIZING/SCAVENGING ACRYLIC CEMENT (February 9, 1984)

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