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
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
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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