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510(k) K964362

KINAMED PROFIX SYSTEM by Kinamed, Inc. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1997
Date Received
November 1, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • 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)
  • K010101 — GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM (May 17, 2001)
  • K003347 — ORTHOPILOT (February 23, 2001)

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