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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 NumberS003
Date Received12/01/2005
Decision Date12/12/2005
Product Code
MDI[ Registered Establishments with MDI ]
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for modifications of the synthes vertical expandable prosthetic titanium rib components such that: 1) dimensional (no decrease in length ofless than4. 7 mm) changes be made to the lumbar extension components; and, 2) tolerance (from +i mm to +0 mm) and dimensional (no decrease in length of less than 2 mm) be made to the inferior cradle components.
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