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510(k) K822780

CERVICAL BRACE by Jerome Medical — Product Code JEC

K822780 is an FDA 510(k) premarket notification submitted by Jerome Medical for the device "CERVICAL BRACE". The FDA issued a decision of Substantially Equivalent on October 6, 1982. The device falls under product code JEC (Component, Traction, Invasive), a Class II device regulated under 21 CFR 888.3040. Jerome Medical has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1982
Date Received
September 14, 1982
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 Jerome Medical

  • K051918 — RESOLVE OPEN BACK HALO RINGS (August 17, 2005)
  • K930021 — J TONGS (December 6, 1995)
  • K930153 — SYSTEM III HALO RING (August 6, 1993)
  • K882877 — JMS CERVICAL TRACTION DEVICE/HALO DEVICE (September 30, 1988)
  • K870053 — TORQUEDRIVER WRENCH (March 11, 1987)
  • K864969 — JMS HALO APPLICATION TRAY (February 18, 1987)
  • K844490 — TRACTION ACCESSORIES (February 21, 1985)
  • K821582 — WARM'N FORM SPORTS SUPPORTS (June 10, 1982)

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