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FDA 510(k), K123691, MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)
FDA 510(k), K123691, MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)
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510(K) Number: K123691
Device Name: MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)
Manufacturer: MEDTRONIC SOFAMOR DANEK, INC.
Device Classification Name: filler, bone void, calcium compound
Regulation Number: 888.3045
Classification Product Code: MQV
Date Received: 12/03/2012
Decision Date: 01/31/2013
Regulation Medical Specialty: Orthopedic
Device Name: MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)
Manufacturer: MEDTRONIC SOFAMOR DANEK, INC.
Device Classification Name: filler, bone void, calcium compound
Regulation Number: 888.3045
Classification Product Code: MQV
Date Received: 12/03/2012
Decision Date: 01/31/2013
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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