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.
 
DeviceRAY FUSION THREADED CAGE (TFC) DEVICE
Generic NameIntervertebral fusion device with bone graft, lumbar
Regulation Number888.3080
ApplicantSTRYKER SPINE
2 Pearl Court
Allendale, NJ 07401
PMA NumberP950019
Supplement NumberS006
Date Received01/20/1999
Decision Date02/05/1999
Reclassified Date 07/12/2007
Product Code MAX 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for modified, lengthened instruments.
-
-