FDA 510(k), K100765, FIXPINE II SYSTEM

FDA 510(k), K100765, FIXPINE II SYSTEM

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510(K) Number: K100765
Device Name: FIXPINE II SYSTEM
Manufacturer: JOYCE BANG
Device Classification Name: Orthosis, Spinal Pedicle Fixation
Regulation Number: MNI
Classification Product Code: 03/17/2010
Date Received: 07/19/2010
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic

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