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510(k) K934161

PROFORM HIP SYSTEM by Stelkast Company — Product Code JDO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 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

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  • 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)

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  • 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)