PMA P110002S040

Device: Mobi-C® Cervical Disc Prosthesis for use at One Level
Applicant: Highridge Medical, LLC
PMA number: P110002
Supplement: S040
Product code: MJO
Decision date: 2026-09-16
Classification: Orthopedic
Generic name: Prosthesis, intervertebral disc
Approval order statement: addition of a new raw material supplier (CAM Bioceramics) for hydroxyapatite powder used in the coating of Mobi-C® inferior and superior endplates, and qualification of a new sealing equipment (CeraTek) for sealing of the final packaging pouch of Mobi-C® devices at the same Viant facility

Current openFDA PMA Record#

Device: Mobi-C® Cervical Disc Prosthesis for use at One Level
Applicant: Highridge Medical, LLC
PMA number: P110002
Supplement: S040
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2026-09-16
Decision code: OK30
Date received: 2026-08-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: addition of a new raw material supplier (CAM Bioceramics) for hydroxyapatite powder used in the coating of Mobi-C® inferior and superior endplates, and qualification of a new sealing equipment (CeraTek) for sealing of the final packaging pouch of Mobi-C® devices at the same Viant facility