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510(k) K983814

GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM by Efratgo, Ltd. HI Tech Bio-Surgical — Product Code JDO

K983814 is an FDA 510(k) premarket notification submitted by Efratgo, Ltd. HI Tech Bio-Surgical for the device "GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM". The FDA issued a decision of Substantially Equivalent on January 14, 1999. The device falls under product code JDO (Device, Fixation, Proximal Femoral, Implant), a Class II device regulated under 21 CFR 888.3030. Efratgo, Ltd. HI Tech Bio-Surgical has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1999
Date Received
October 28, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Fixation, Proximal Femoral, Implant
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Efratgo, Ltd. HI Tech Bio-Surgical

  • K083648 — GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL (May 14, 2009)
  • K043233 — GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL (February 1, 2005)

Other clearances for product code JDO

  • K230764 — OsteoCentric Integrated Hip Fastener System (April 18, 2023)
  • K213126 — Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, V (September 29, 2022)
  • K210247 — OsteoCentric Integrated Hip Fastener System (April 30, 2021)
  • K193029 — CONQUEST FN (February 28, 2020)
  • K173826 — THP Hip Fracture Plating System (February 7, 2018)
  • K172785 — CONQUEST FN (December 22, 2017)
  • K152686 — CONQUEST FN (March 17, 2016)
  • K140018 — TSP HIP FRACTURE PLATING SYSTEM (April 4, 2014)
  • K080685 — HIPLOC COMPRESSION HIP SCREW (August 15, 2008)
  • K080434 — INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW (April 10, 2008)

FDA data resources