Home / 510(k) Clearances / K023360

510(k) K023360

LEFORTE SYSTEM BONE PLATE by Jeil Medical Corporation — Product Code KTW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2002
Date Received
October 7, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Jeil Medical Corporation

  • K252826 — ARIX Femur Nail System (December 10, 2025)
  • K251431 — FIX-C PEEK ACIF SA System (June 27, 2025)
  • K243973 — FIX-L PEEK PLIF and T-PLIF System (June 12, 2025)
  • K242751 — ARIX Pectus Bar System (May 30, 2025)
  • K242247 — ARIX Femur Nail System (April 22, 2025)
  • K243915 — FIX-C 3D Ti ACIF System (February 18, 2025)
  • K243004 — Xpine Spinal Fixation System (November 8, 2024)
  • K231251 — FlexWing Anterior Cervical Plate System (July 24, 2024)
  • K233912 — ARIX Cannulated Screw System (March 11, 2024)
  • K231887 — ARIX Ankle Distal Tibia System (December 14, 2023)

Other clearances for product code KTW

  • K182285 — PK High Tibial Osteotomy Correction System (June 20, 2019)
  • K171606 — AOS Anterolateral Proximal Humeral Plate (June 22, 2017)
  • K170693 — Phantom Small Bone Intramedullary Nail System (June 19, 2017)
  • K160409 — AOS Anterolateral Proximal Humeral Plate (March 15, 2016)
  • K122541 — ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) (September 20, 2012)
  • K080590 — AOS PROXIMAL HUMERAL PLATE (May 6, 2008)
  • K080109 — SYNTHES (USA) MODULAR BLADE PLATE SYSTEM (March 20, 2008)
  • K062920 — ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP (November 13, 2006)
  • K012645 — REPROCESSED EBI EXTERNAL FIXATION DEVICES (June 24, 2002)
  • K012634 — REPROCESSED EXTERNAL FIXATION DEVICE (June 24, 2002)