FDA 510(k), K130613, CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEM

FDA 510(k), K130613, CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEM

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510(K) Number: K130613
Device Name: CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEM
Manufacturer: LAURA CATTABRIGA
Device Classification Name: Screw, Fixation, Bone
Regulation Number: HWC
Classification Product Code: KXA
Date Received: 03/07/2013
Decision Date: 01/22/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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