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510(k) K072250

SUPERCABLE GRIP AND PLATE SYSTEM by Kinamed, Inc. — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2007
Date Received
August 13, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • 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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