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FDA 510(k), K071790, GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE SYSTEM
FDA 510(k), K071790, GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE SYSTEM
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510(K) Number: K071790
Device Name: GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE SYSTEM
Manufacturer: JASON SELLS
Device Classification Name: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Regulation Number: MBH
Classification Product Code: 07/02/2007
Date Received: 08/17/2007
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE SYSTEM
Manufacturer: JASON SELLS
Device Classification Name: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Regulation Number: MBH
Classification Product Code: 07/02/2007
Date Received: 08/17/2007
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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