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

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | 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 PMA to get an up-to-date view of this device.
 
Trade NameBIRMINGHAM HIP RESURFACING (BHR) SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/metal, resurfacing
Generic Nametotal hip resurfacing prosthesis, metal-on-metal
ApplicantSMITH & NEPHEW, INC.
PMA NumberP040033
Supplement NumberS021
Date Received06/28/2011
Decision Date07/27/2011
Product Code
NXT[ Registered Establishments with NXT ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Use of a new degreasing system at a contract manufacturer.
-
-