|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||EXACTECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM|
|Classification Name||prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change from performing fluorescent penetrant inspection (fpi) at qc labs to performing the inspection step in-house as well as a process change at ceramtec.