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510(k) K952943

CONSENSUS ALL POLY TIBIA by U.S. Medical Products, Inc. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1996
Date Received
June 26, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
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)
  • 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)
  • K960151 — CONSENSUS 26MM 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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