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510(k) K770161

MICROFENESTRATED HIP REPLACEMENT COMPON. by Medishield, Inc. — Product Code JDG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1977
Date Received
January 24, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Femoral Component, Cemented, Metal
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

Other clearances by Medishield, Inc.

  • K781103 — SPECTRASCAN (September 27, 1978)
  • K780645 — HMD-2000 BATTERY-POWERED MINI-DRILL, THE (May 3, 1978)
  • K780646 — AIR-PWOERED COLDRILL (April 28, 1978)
  • K780202 — MONOMER EVACUATION SYSTEM (February 21, 1978)
  • K761021 — ANKLE INSTRUMENTS (FREEMAN-SWANSON) (November 23, 1976)
  • K761020 — ANKLE (FREEMAN-SWANSON) (November 23, 1976)
  • K760668 — SELECTATEC SYSTEM (September 27, 1976)

Other clearances for product code JDG

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  • K193546 — Distal Centralizers (September 25, 2020)
  • K173499 — Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (March 19, 2018)
  • K001984 — PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT (September 27, 2000)
  • K992234 — THE TAPER-FIT TOTAL HIP SYSTEM (November 10, 1999)
  • K962002 — AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM (August 8, 1996)
  • K955171 — NEXLOCK FEMORAL STEM (February 9, 1996)
  • K953653 — LUBINUS SP II HIP SYSTEM (November 6, 1995)
  • K953067 — HIP FRACTURE STEM FENESTRATION PLUG (August 21, 1995)
  • K945783 — ORTHOMET TITANIUM HYBRID FEMORAL STEM (May 30, 1995)