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 NumberS005
Date Received01/10/2008
Decision Date01/24/2008
Product Code
MDI[ Registered Establishments with MDI ]
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for minor changes to the labeling for the vertical expandable prosthetic titanium rib (veptr) system. The veptr system is indicated for thetreatment of thoracic insufficiency syndrome (tis) in skeletally immature patients. Tis is defined as the inability of the thorax to support normal respiration or lung growth. For the purpose of identifying potential tis patients, the categories in which tis patients fall are as follows:1) flail chest syndrome;2) constrictive chest wall syndrome, including; anda. Rib fusion and scoliosisb. Hypoplastic thorax syndrome, includingc. Jeune's syndromed. Achondroplasiae. Jarcho-levin syndromef. Ellis van creveld syndrome3) progressive scoliosis of congenital or neurogenic origin without rib anomaly.
-
-