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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS
Classification Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
Product Code: LPH
Device Class: 2
Regulation Number: 888.3358
Medical Specialty: Orthopedic
Registered Establishment Name: Zimmer Biomet Canada DFE
Registered Establishment Number: 3012392319
Premarket Submission Number: K030055
Owner/Operator: ZIMMER, INC.
Owner/Operator Number: 1822565
Establishment Operations: Foreign Exporter
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