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) | 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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceREFLECTION CERAMIC HIP SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantSmith & Nephew, Inc.
1450 Brooks Rd.
Memphis, TN 38116
PMA NumberP030022
Supplement NumberS025
Date Received06/06/2013
Decision Date08/30/2013
Withdrawal Date08/31/2022
Product Code MRA 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR 1) ADDITIONAL SIZES OF R3 CERAMIC LINERS; AND 2) REVISION OF THE REFLECTION CERAMIC HIP SYSTEM LABELING (SURGICAL TECHNIQUE MANUAL AND SURGEON LABELING) TO REFLECT THE ADDITIONAL COMPONENTS.
-
-