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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: PRESTIGE Cervical Disc
Classification Name: PROSTHESIS, INTERVERTEBRAL DISC
Product Code: MJO
Device Class: 3
Registered Establishment Name: MEDTRONIC SOFAMOR DANEK USA, INC.
Registered Establishment Number: 1030489
Premarket Submission Number: P060018
Owner/Operator: Medtronic, Inc.
Owner/Operator Number: 2112641
Establishment Operations: Specification Developer
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