PMA P110009S022

Device: Mobi-C Cervical Disc Prosthesis (for Two-Level)
Applicant: Highridge Medical, LLC
PMA number: P110009
Supplement: S022
Product code: MJO
Decision date: 2019-11-13
Classification: Prosthesis, Intervertebral Disc
Generic name: Prosthesis, intervertebral disc
Approval order statement: Approval for a new manufacturing site to be used for kitting and shipping of Mobi-C as well as reconditioning and servicing of instruments from the field for reuse.

Current openFDA PMA Record#

Device: Mobi-C Cervical Disc Prosthesis (for Two-Level)
Applicant: Highridge Medical, LLC
PMA number: P110009
Supplement: S022
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2019-11-13
Decision code: APPR
Date received: 2019-09-04
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a new manufacturing site to be used for kitting and shipping of Mobi-C as well as reconditioning and servicing of instruments from the field for reuse.