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510(k) K032950

GEM INSET PATELLAR COMPONENT by Kinamed, Inc. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2003
Date Received
September 22, 2003
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

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  • K013982 — KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT (May 21, 2002)
  • K010101 — GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM (May 17, 2001)
  • K003347 — ORTHOPILOT (February 23, 2001)
  • K994214 — GEM KNEE SYSTEM (July 19, 2000)

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