PMA P110009S016

Device
MOBI-C CERVICAL DISC PROSTHESIS
Applicant
Highridge Medical, LLC
PMA number
P110009
Supplement
S016
Product code
MJO
Decision date
2017-03-03
Classification
Prosthesis, Intervertebral Disc
Generic name
Prosthesis, intervertebral disc
Approval order statement
Approval for a manufacturing site located at Millstone Medical Outsourcing, 8836 Polk Lane, Suite 100, Olive Branch Mississippi for kitting and shipping of new components as well as reconditioning and servicing of used instruments from the field for reuse.

Current openFDA PMA Record#

Device
MOBI-C CERVICAL DISC PROSTHESIS
Applicant
Highridge Medical, LLC
PMA number
P110009
Supplement
S016
Product code
MJO
Generic name
Prosthesis, intervertebral disc
Decision date
2017-03-03
Decision code
APPR
Date received
2016-11-01
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a manufacturing site located at Millstone Medical Outsourcing, 8836 Polk Lane, Suite 100, Olive Branch Mississippi for kitting and shipping of new components as well as reconditioning and servicing of used instruments from the field for reuse.