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 NameASCENSION PIP
Classification Namefinger semi-constrained pyrolytic carbon uncemented prosthesis
Generic Namefinger semi-constrained pyrolytic carbon uncemented prosthesis
Applicant
Smith & Nephew, Inc.
7135 goodlett farms pkwy.
cordova, TN 38016
HDE NumberH010005
Supplement NumberS004
Date Received10/23/2007
Decision Date01/03/2008
Product Code
NEG[ Registered Establishments with NEG ]
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 to add a hydroxyapatite (ha) coating to the stem of the ascension pip proximal and distal components.
-
-