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510(k) K062920

ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP by Orthofix Srl — Product Code KTW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2006
Date Received
September 28, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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Other clearances for product code KTW

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  • K122541 — ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) (September 20, 2012)
  • K080590 — AOS PROXIMAL HUMERAL PLATE (May 6, 2008)
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  • K023360 — LEFORTE SYSTEM BONE PLATE (October 25, 2002)
  • K012645 — REPROCESSED EBI EXTERNAL FIXATION DEVICES (June 24, 2002)
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