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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Classification Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
Product Code: HSD
Device Class: 2
Regulation Number: 888.3690
Medical Specialty: Orthopedic
Registered Establishment Name: Zimmer Biomet Pty Ltd
Registered Establishment Number: 3035366890
Premarket Submission Number: K051843
Owner/Operator: Zimmer Biomet APAC DFE
Owner/Operator Number: 10056128
Establishment Operations: Foreign Exporter
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