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FDA 510(k), K002740, TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS
FDA 510(k), K002740, TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS
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510(K) Number: K002740
Device Name: TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS
Manufacturer: SMITH & NEPHEW, INC.
Device Classification Name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
Regulation Number: 888.3560
Classification Product Code: JWH
Date Received: 09/01/2000
Decision Date: 11/30/2000
Regulation Medical Specialty: Orthopedic
Device Name: TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS
Manufacturer: SMITH & NEPHEW, INC.
Device Classification Name: prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer
Regulation Number: 888.3560
Classification Product Code: JWH
Date Received: 09/01/2000
Decision Date: 11/30/2000
Regulation Medical Specialty: Orthopedic
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