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510(k) K080109

SYNTHES (USA) MODULAR BLADE PLATE SYSTEM by Synthes (Usa) — Product Code KTW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2008
Date Received
January 15, 2008
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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  • K103002 — SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM (March 2, 2011)
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Other clearances for product code KTW

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  • K160409 — AOS Anterolateral Proximal Humeral Plate (March 15, 2016)
  • K122541 — ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) (September 20, 2012)
  • K080590 — AOS PROXIMAL HUMERAL PLATE (May 6, 2008)
  • K062920 — ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP (November 13, 2006)
  • K023360 — LEFORTE SYSTEM BONE PLATE (October 25, 2002)
  • K012645 — REPROCESSED EBI EXTERNAL FIXATION DEVICES (June 24, 2002)
  • K012634 — REPROCESSED EXTERNAL FIXATION DEVICE (June 24, 2002)