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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NameVERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR)
Classification Nameprosthesis, rib replacement
Generic Nameprosthesis, rib replacement
Regulation Number888.3070
Applicant
Synthes Spine
325 paramount dr.
raynham, MA 02767
HDE NumberH030009
Supplement NumberS007
Date Received02/03/2011
Decision Date03/04/2011
Product Code
MDI[ Registered Establishments with MDI ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Use of a new, larger turning machine and change to performing the "cut-off" operation during the turning process.
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