Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 NumberS002
Date Received06/23/2005
Decision Date07/11/2005
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) the angle between the two legs of the s-hookcomponent be changed from 45 to 90 degrees; and, 2) the last hole on the lumbar extension component be removed, and material be added to the lumbar extension component so as to create a blended transition from the circular section to the t -section.
-
-