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510(k) K934162

PROFORM HA HIP SYSTEM by Stelkast Company — Product Code JDO

K934162 is an FDA 510(k) premarket notification submitted by Stelkast Company for the device "PROFORM HA HIP SYSTEM". The FDA issued a decision of SN on March 9, 1994. The device falls under product code JDO (Device, Fixation, Proximal Femoral, Implant), a Class II device regulated under 21 CFR 888.3030. Stelkast Company has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
March 9, 1994
Date Received
August 27, 1993
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 Stelkast Company

  • K190276 — Provident II Hip Stem (March 8, 2019)
  • K173875 — GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert (January 19, 2018)
  • K162222 — GENflex2 Total Knee System (September 7, 2016)
  • K122883 — EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SY (August 5, 2013)
  • K122773 — CROSS-OVER ACETABULAR SHELL & LINER (October 9, 2012)
  • K094035 — EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM (March 24, 2011)
  • K081458 — PROVEN STEM EXTENDER (June 6, 2008)
  • K063211 — PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT (January 18, 2007)
  • K051976 — PROVEN REVISION MODULAR TIBIAL TRAY (October 17, 2005)
  • K033944 — STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD (March 12, 2004)

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