|Trade Name||TOTAL TRAPEZIO METACARPAL PROSTHESIS|
|Classification Name||prosthesis, finger, constrained, metal/polymer|
|Applicant||AVANTA ORTHOPAEDICS, INC.|
|Supplement Type||normal 180 day track|
|Supplement Reason|| process change: packaging|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for 1) packaging the implant in a single box containing both the proximal and distal components and changing package labels accordingly, and 2) changing the color of stock used for printing box labels.