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FDA 510(k), K030612, GENESIS II TOTAL KNEE SYSTEM
FDA 510(k), K030612, GENESIS II TOTAL KNEE SYSTEM
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510(K) Number: K030612
Device Name: GENESIS II TOTAL KNEE SYSTEM
Manufacturer: KIM P KELLEY
Device Classification Name: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Regulation Number: MBH
Classification Product Code: KXA
Date Received: 02/26/2003
Decision Date: 05/27/2003
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: GENESIS II TOTAL KNEE SYSTEM
Manufacturer: KIM P KELLEY
Device Classification Name: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Regulation Number: MBH
Classification Product Code: KXA
Date Received: 02/26/2003
Decision Date: 05/27/2003
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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