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510(k) K960151

CONSENSUS 26MM COCRMO FEMORAL HEAD by U.S. Medical Products, Inc. — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1996
Date Received
January 11, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type

Other clearances by U.S. Medical Products, Inc.

  • K962215 — CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER (August 15, 1996)
  • K954818 — CONSENSUS POSTERIOR STABILIZED KNEE (May 22, 1996)
  • K953443 — CONSENSUS PCL SUBSITUTING TIBIAL INSERT (April 26, 1996)
  • K952943 — CONSENSUS ALL POLY TIBIA (April 1, 1996)
  • K960302 — CONSENSUS ACETABULAR SHELL, ALL UHMWPE (April 1, 1996)
  • K960340 — CONSENSUS APEX DOME HOLE PLUG (March 15, 1996)
  • K960156 — CONSENSUS 32MM COCRMO FEMORAL HEAD (February 21, 1996)
  • K960339 — CONSENSUS 22MM COCRMO FEMORAL HEAD (February 21, 1996)
  • K955386 — CONSENSUS ZIRCONIA FEMORAL HEAD (February 20, 1996)
  • K953792 — CONSENSUS ZIRCONIA HEAD SIZE -3.5, 0, +5 (November 6, 1995)

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