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510(k) K931578

TEXAS SCOTTISH RITE EASY/LOCK FIXATOR by Applied Osteo Systems, Inc. — Product Code JEC

K931578 is an FDA 510(k) premarket notification submitted by Applied Osteo Systems, Inc. for the device "TEXAS SCOTTISH RITE EASY/LOCK FIXATOR". The FDA issued a decision of Substantially Equivalent on February 22, 1994. The device falls under product code JEC (Component, Traction, Invasive), a Class II device regulated under 21 CFR 888.3040. Applied Osteo Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1994
Date Received
March 30, 1993
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 Applied Osteo Systems, Inc.

  • K935383 — FEMROD AND FEMROD RECON INSERT (March 21, 1995)
  • K933995 — TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION (January 27, 1995)
  • K944501 — TRUE/FLEX INTRAMEDULLARY ROD END-CAP (November 28, 1994)
  • K941048 — TRUE/LOK MONOLATERAL/BILATERAL FIXATOR (October 3, 1994)
  • K943160 — INTERFERENCE SCREW (September 30, 1994)
  • K932853 — PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS (February 22, 1994)
  • K934148 — TRUE/FLEX CLAVICLE RODS (February 22, 1994)
  • K926465 — FEMORAL INTRAMEDULLARY RODS (August 25, 1993)
  • K924657 — TRUE/FLEX METATARSAL RODS (November 24, 1992)
  • K924656 — TRUE/ FLEX FIBULA RODS (November 24, 1992)

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