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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Alpha System
Classification Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
Product Code: JDI
Device Class: 2
Regulation Number: 888.3350
Medical Specialty: Orthopedic
Registered Establishment Name: ZIMMER MANUFACTURING B.V.
Registered Establishment Number: 2648920
Premarket Submission Number: K950312
Owner/Operator: ZIMMER, INC.
Owner/Operator Number: 1822565
Establishment Operations: Manufacturer
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