• 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.
 
DeviceMobi-C Cervical Disc Prosthesis
Generic Nameprosthesis, intervertebral disc
ApplicantZimmer Biomet Spine, Inc.
10225 westmoor drive
westminster, CO 80021
PMA NumberP110009
Supplement NumberS020
Date Received01/05/2018
Decision Date05/30/2018
Product Code MJO 
Advisory Committee Orthopedic
Clinical TrialsNCT00389597
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for an update of labeling with 84 month data.
-
-