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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: NexGen Gender Sol. Female (GSF) Fem
Classification Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Product Code: JWH
Device Class: 2
Regulation Number: 888.3560
Medical Specialty: Orthopedic
Registered Establishment Name: Zimmer Orthopedic Mfg Ltd
Registered Establishment Number: 3007963827
Premarket Submission Number: K060370
Owner/Operator: ZIMMER, INC.
Owner/Operator Number: 1822565
Establishment Operations: Manufacturer
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