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510(k) K770066

TIBIAL COMPRESSION FRAM FOR FRACTURES by Richard F. Kronner, M.D. — Product Code JEC

K770066 is an FDA 510(k) premarket notification submitted by Richard F. Kronner, M.D. for the device "TIBIAL COMPRESSION FRAM FOR FRACTURES". The FDA issued a decision of Substantially Equivalent on March 30, 1977. The device falls under product code JEC (Component, Traction, Invasive), a Class II device regulated under 21 CFR 888.3040. Richard F. Kronner, M.D. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1977
Date Received
January 12, 1977
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 Richard F. Kronner, M.D.

  • K800502 — ADDITIONAL COMPONENTS KRONNER COMPRES (April 2, 1980)
  • K770065 — ADJUSTABLE ARM SUPPORT (February 2, 1977)

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