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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: Persona Partial Knee System
Classification Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Product Code: HSX
Device Class: 2
Regulation Number: 888.3520
Medical Specialty: Orthopedic
Registered Establishment Name: Zimmer Biomet Taiwan Co., Ltd.
Premarket Submission Number: K161592
Owner/Operator: Zimmer Biomet APAC DFE
Owner/Operator Number: 10056128
Establishment Operations: Foreign Exporter
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