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510(k) K011815

SYNTHES LCP PROXIMAL HUMERUS PLATES by Synthes (Usa) — Product Code KTW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2001
Date Received
June 11, 2001
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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  • K120275 — SYNTHES ACIS/VERTEBRAL SPACER CR (May 25, 2012)
  • K111667 — SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS (December 5, 2011)
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  • K110789 — SYNTHES STERNAL ZIPFIX SYSTEM (July 28, 2011)
  • K103002 — SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM (March 2, 2011)
  • K103243 — 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM (January 21, 2011)

Other clearances for product code KTW

  • K182285 — PK High Tibial Osteotomy Correction System (June 20, 2019)
  • K171606 — AOS Anterolateral Proximal Humeral Plate (June 22, 2017)
  • K170693 — Phantom Small Bone Intramedullary Nail System (June 19, 2017)
  • 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)
  • K080109 — SYNTHES (USA) MODULAR BLADE PLATE SYSTEM (March 20, 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)