FDA 510(k) Application Details - K052918

Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

  More FDA Info for this Device
510(K) Number K052918
Device Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant ALLIANCE MEDICAL CORP.
10232 SOUTH 51ST ST.
PHOENIX, AZ 85044 US
Other 510(k) Applications for this Company
Contact MOIRA BARTON
Other 510(k) Applications for this Contact
Regulation Number 888.3030

  More FDA Info for this Regulation Number
Classification Product Code KTT
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 10/17/2005
Decision Date 01/27/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact