PMA P110009S013

Device: MOBI-C CERVICAL DISC PROSTHESIS
Applicant: Highridge Medical, LLC
PMA number: P110009
Supplement: S013
Product code: MJO
Decision date: 2016-01-21
Classification: Prosthesis, Intervertebral Disc
Generic name: Prosthesis, intervertebral disc
Approval order statement: FOUR MANUFACTURING CHANGES, WHICH INCLUDED REPLACEMENT OF A WIRE CUTTING MACHINE, ADDITION OF NEW POLISHING STATIONS, UPDATES TO LASER MARKING MACHINES, AND THE ADDITION OF UPDATED TENSILE TESTING MACHINES.

Current openFDA PMA Record#

Device: MOBI-C CERVICAL DISC PROSTHESIS
Applicant: Highridge Medical, LLC
PMA number: P110009
Supplement: S013
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2016-01-21
Decision code: OK30
Date received: 2015-12-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: FOUR MANUFACTURING CHANGES, WHICH INCLUDED REPLACEMENT OF A WIRE CUTTING MACHINE, ADDITION OF NEW POLISHING STATIONS, UPDATES TO LASER MARKING MACHINES, AND THE ADDITION OF UPDATED TENSILE TESTING MACHINES.