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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: INFUSE BONEGRAFT Tibial Fracture
Classification Name: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD, OSTEOINDUCTION
Product Code: MPW
Device Class: 3
Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.
Registered Establishment Number: 1030489
Owner/Operator: MEDTRONIC INC.
Owner/Operator Number: 2112641
Establishment Operations: Specification Developer
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