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510(k) K012634

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

K012634 is an FDA 510(k) premarket notification submitted by Alliance Medical, Inc. for the device "REPROCESSED EXTERNAL FIXATION DEVICE". The FDA issued a decision of Substantially Equivalent on June 24, 2002. The device falls under product code KTW (Appliance, Fixation, Nail/Blade/Plate Combination, Single Component), a Class II device regulated under 21 CFR 888.3030. Alliance Medical, Inc. has at least 10 other 510(k) clearances on record.

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.

  • K060648 — REPROCESSED PHACOEMULSIFICATION TIPS (March 19, 2007)
  • K061045 — REPROCESSED ELECTROPHYSIOLOGY CATHETERS (August 31, 2006)
  • K051438 — VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM) (April 4, 2006)
  • 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)

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)

FDA data resources