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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED
Classification Name: PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Product Code: KRR
Device Class: 2
Regulation Number: 888.3540
Medical Specialty: Orthopedic
Registered Establishment Name: Zimmer Biomet Canada DFE
Registered Establishment Number: 3012392319
Premarket Submission Number: K000827
Owner/Operator: ZIMMER, INC.
Owner/Operator Number: 1822565
Establishment Operations: Foreign Exporter
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