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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Bipolar Hip Device
Classification Name: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
Product Code: KWY
Device Class: 2
Regulation Number: 888.3390
Medical Specialty: Orthopedic
Registered Establishment Name: ZIMMER MANUFACTURING B.V.
Registered Establishment Number: 2648920
Premarket Submission Number: K833991
Owner/Operator: ZIMMER, INC.
Owner/Operator Number: 1822565
Establishment Operations: Manufacturer
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