|Device||CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM|
|Classification Name||prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|
|Generic Name||prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the replacement of two grinding machines and addition of one piece of proof testing equipment at the plochingen, germany facility and addition of a grinding machine and piece of proof testing equipment at the marktredwitz, germany facility.