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FDA 510(k), K122513, CLEARED UNDER GRAFTON II EDBM
FDA 510(k), K122513, CLEARED UNDER GRAFTON II EDBM
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510(K) Number: K122513
Device Name: CLEARED UNDER GRAFTON II EDBM
Manufacturer: MEDTRONIC SOFAMOR DANEK, INC.
Device Classification Name: filler, bone void, osteoinduction (w/o human growth factor)
Regulation Number: 888.3045
Classification Product Code: MBP
Date Received: 08/17/2012
Decision Date: 03/06/2013
Regulation Medical Specialty: Orthopedic
Device Name: CLEARED UNDER GRAFTON II EDBM
Manufacturer: MEDTRONIC SOFAMOR DANEK, INC.
Device Classification Name: filler, bone void, osteoinduction (w/o human growth factor)
Regulation Number: 888.3045
Classification Product Code: MBP
Date Received: 08/17/2012
Decision Date: 03/06/2013
Regulation Medical Specialty: Orthopedic
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- 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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