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510(k) K012634

REPROCESSED EXTERNAL FIXATION DEVICE by Alliance Medical, Inc. — Product Code KTW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2002
Date Received
August 13, 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

Other clearances by Alliance Medical, Inc.

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  • K060049 — REPROCESSED COMPRESSION SLEEVES (February 24, 2006)
  • K060091 — ALLIANCE MEDICAL CORPORATION REPROCESSED COMPRESSION SLEEVES (February 17, 2006)
  • K053316 — REPROCESSED COMPRESSION SLEEVES (February 13, 2006)
  • K052918 — REPROCESSED EXTERNAL FIXATION DEVICES (January 27, 2006)
  • K052414 — REPROCESSED ELECTROPHYSIOLOGY CATHETER (November 16, 2005)
  • K052603 — REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS (November 16, 2005)
  • K050518 — REPROCESSED PHACOEMUISIFICATION TIPS (September 23, 2005)

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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)
  • 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)