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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: INFUSE BONEGRAFT/ LT-CAGE Lumbar TF
Classification Name: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH METAL PROSTHESIS, OSTEOINDUCTION
Product Code: NEK
Device Class: 3
Registered Establishment Name: MEDTRONIC PUERTO RICO OPERATIONS CO., HUMACAO
Registered Establishment Number: 2647346
Owner/Operator: MEDTRONIC INC.
Owner/Operator Number: 2112641
Establishment Operations: Manufacturer
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