• 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.
Generic Nameprosthesis, intervertebral disc
ApplicantZimmer Biomet Spine, Inc.
10225 westmoor drive
westminster, CO 80021
PMA NumberP110009
Supplement NumberS015
Date Received09/30/2016
Decision Date05/05/2017
Product Code MJO 
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for manufacturing sites located at: 1) SAS Etablissements Maurice, MARLE, Zi Rue Lavoisier, Bp 46, Nogent France; 2) Marie Finishing SAS, 22 Rue de IaMollanche Sorbiers, Loire 42290, France; and 3) Marie Sferic SAS, Zone Artisanale, Rue du Courtois Prolongee 41500 MENARS France, for polishing endplates and machining the mobile insert of the device.