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FDA 510(k), K123907, PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,
FDA 510(k), K123907, PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,
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510(K) Number: K123907
Device Name: PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,
Manufacturer: BIOMET MANUFACTURING CORP.
Device Classification Name: prosthesis, knee, patello/femoral, semi-constrained, cemented, metal/polymer
Regulation Number: 888.3540
Classification Product Code: KRR
Date Received: 12/19/2012
Decision Date: 09/03/2013
Regulation Medical Specialty: Orthopedic
Device Name: PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS,
Manufacturer: BIOMET MANUFACTURING CORP.
Device Classification Name: prosthesis, knee, patello/femoral, semi-constrained, cemented, metal/polymer
Regulation Number: 888.3540
Classification Product Code: KRR
Date Received: 12/19/2012
Decision Date: 09/03/2013
Regulation Medical Specialty: Orthopedic
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