PMA P110002S038

Device: Mobi-C® Cervical Disc Prosthesis
Applicant: Highridge Medical, LLC
PMA number: P110002
Supplement: S038
Product code: MJO
Decision date: 2026-03-23
Classification: Orthopedic
Generic name: Prosthesis, intervertebral disc
Approval order statement: addition of a new raw material supplier (IKH) for titanium powder used in the plasma spray coating of Mobi-C® inferior and superior endplates, and qualification of a back-up final cleaning line (HAMO 210 #LA2165) for cleaning of Mobi-C® inserts and jaws performed at the same Viant facility

Current openFDA PMA Record#

Device: Mobi-C® Cervical Disc Prosthesis
Applicant: Highridge Medical, LLC
PMA number: P110002
Supplement: S038
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2026-03-23
Decision code: OK30
Date received: 2026-03-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: addition of a new raw material supplier (IKH) for titanium powder used in the plasma spray coating of Mobi-C® inferior and superior endplates, and qualification of a back-up final cleaning line (HAMO 210 #LA2165) for cleaning of Mobi-C® inserts and jaws performed at the same Viant facility