• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


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 NamePRODISC-L TOTAL DISC REPLACEMENT
Classification Nameprosthesis, intervertebral disc
Generic Nameprosthesis,intervertebral disc
ApplicantSYNTHES SPINE
PMA NumberP050010
Supplement NumberS010
Date Received09/29/2010
Decision Date03/03/2011
Product Code
MJO[ Registered Establishments with MJO ]
Advisory Committee Orthopedic
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change from a manual deburring process to an automated brush deburring process.
-
-