PMA P070001S029

Device: prodisc® C
Applicant: Centinel Spine, LLC
PMA number: P070001
Supplement: S029
Product code: MJO
Decision date: 2025-07-30
Classification: Orthopedic
Generic name: Prosthesis, intervertebral disc
Approval order statement: Approval for the addition of APS Materials Inc (FEI 1000149660) as an alternate commercially pure titanium raw material supplier and transition from manual to automated grit process for surface modification of endplate components

Current openFDA PMA Record#

Device: prodisc® C
Applicant: Centinel Spine, LLC
PMA number: P070001
Supplement: S029
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2025-07-30
Decision code: OK30
Date received: 2025-07-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the addition of APS Materials Inc (FEI 1000149660) as an alternate commercially pure titanium raw material supplier and transition from manual to automated grit process for surface modification of endplate components