PMA P110009S015

Device: MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)
Applicant: Highridge Medical, LLC
PMA number: P110009
Supplement: S015
Product code: MJO
Decision date: 2017-05-05
Classification: Prosthesis, Intervertebral Disc
Generic name: Prosthesis, intervertebral disc
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.

Current openFDA PMA Record#

Device: MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)
Applicant: Highridge Medical, LLC
PMA number: P110009
Supplement: S015
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2017-05-05
Decision code: APPR
Date received: 2016-09-30
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
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.