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510(k) K010101

GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM by Kinamed, Inc. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2001
Date Received
January 11, 2001
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 Kinamed, Inc.

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  • K072250 — SUPERCABLE GRIP AND PLATE SYSTEM (November 9, 2007)
  • K050897 — NAVIPRO SHOULDER SOFTWARE MODULE (May 24, 2005)
  • K033668 — NAVIPRO KNEE SOFTWARE MODULE (March 11, 2004)
  • K032950 — GEM INSET PATELLAR COMPONENT (December 19, 2003)
  • K030256 — ISO-ELASTIC CERCLAGE SYSTEM (October 21, 2003)
  • K020764 — NAVIPRO (June 3, 2002)
  • K013982 — KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT (May 21, 2002)
  • K003347 — ORTHOPILOT (February 23, 2001)
  • K994214 — GEM KNEE SYSTEM (July 19, 2000)

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