PMA P110009S029

Device
Mobi-C Cervical Disc Prosthesis Two-level
Applicant
Highridge Medical, LLC
PMA number
P110009
Supplement
S029
Product code
MJO
Decision date
2021-02-17
Generic name
Prosthesis, intervertebral disc
Approval order statement
Qualify an existing manufacturing site as an alternate supplier to perform the titanium (Ti) and hydroxyapatite (HA) coating operations for the Mobi-C® implant endplates.

Current openFDA PMA Record#

Device
Mobi-C Cervical Disc Prosthesis Two-level
Applicant
Highridge Medical, LLC
PMA number
P110009
Supplement
S029
Product code
MJO
Generic name
Prosthesis, intervertebral disc
Decision date
2021-02-17
Decision code
OK30
Date received
2021-01-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Qualify an existing manufacturing site as an alternate supplier to perform the titanium (Ti) and hydroxyapatite (HA) coating operations for the Mobi-C® implant endplates.