|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 |
Changes to the process for use of the burst test fixture, which is used to evaluate the seal strength of the packaging.