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510(k) K920149

OSTEO EX-FI-RE by Osteo AG — Product Code JEC

K920149 is an FDA 510(k) premarket notification submitted by Osteo AG for the device "OSTEO EX-FI-RE". The FDA issued a decision of Substantially Equivalent on April 9, 1992. The device falls under product code JEC (Component, Traction, Invasive), a Class II device regulated under 21 CFR 888.3040. Osteo AG has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1992
Date Received
January 10, 1992
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 Osteo AG

  • K933340 — OSTEO INTERLOCKING-COMPRESSION NAIL (June 30, 1994)
  • K922195 — OSTEO FEMORAL NAIL (July 23, 1992)
  • K922196 — OSTEO TIBIA NAIL (July 23, 1992)
  • K922193 — OSTEO KIRSCHNER WIRE (July 23, 1992)
  • K922194 — OSTEO STEINMANN PIN (July 23, 1992)
  • K920037 — OSTEO COMPRESSION HIP SCREW (March 11, 1992)
  • K914374 — OSTEO CERCLAGE WIRE (December 30, 1991)
  • K913559 — OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR (November 7, 1991)

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