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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: KXA
Date Received: 03/17/2010
Decision Date: 07/19/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: FIXPINE II SYSTEM
Manufacturer: JOYCE BANG
Device Classification Name: Orthosis, Spinal Pedicle Fixation
Regulation Number: MNI
Classification Product Code: KXA
Date Received: 03/17/2010
Decision Date: 07/19/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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