FDA 510(k), K113871, PRO-DENSE BONE GRAFT SUBSTITUTE
FDA 510(k), K113871, PRO-DENSE BONE GRAFT SUBSTITUTE
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510(K) Number: K113871
Device Name: PRO-DENSE BONE GRAFT SUBSTITUTE
Manufacturer: WRIGHT MEDICAL TECHNOLOGY, INC.
Device Classification Name: Filler, Bone Void, Calcium Compound
Regulation Number: 888.3045
Classification Product Code: MQV
Date Received: 12/30/2011
Decision Date: 03/25/2013
Regulation Medical Specialty: Orthopedic
Device Name: PRO-DENSE BONE GRAFT SUBSTITUTE
Manufacturer: WRIGHT MEDICAL TECHNOLOGY, INC.
Device Classification Name: Filler, Bone Void, Calcium Compound
Regulation Number: 888.3045
Classification Product Code: MQV
Date Received: 12/30/2011
Decision Date: 03/25/2013
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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