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FDA 510(k), K072160, NEXGEN TRABECULAR METAL TIBIAL TRAY
FDA 510(k), K072160, NEXGEN TRABECULAR METAL TIBIAL TRAY
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510(K) Number: K072160
Device Name: NEXGEN TRABECULAR METAL TIBIAL TRAY
Manufacturer: BRANDON HIPSHER
Device Classification Name: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Regulation Number: MBH
Classification Product Code: KXA
Date Received: 08/06/2007
Decision Date: 09/05/2007
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: NEXGEN TRABECULAR METAL TIBIAL TRAY
Manufacturer: BRANDON HIPSHER
Device Classification Name: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Regulation Number: MBH
Classification Product Code: KXA
Date Received: 08/06/2007
Decision Date: 09/05/2007
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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