PMA P050010S027

Device: PRODISC L
Applicant: Centinel Spine, LLC
PMA number: P050010
Supplement: S027
Product code: MJO
Decision date: 2025-09-02
Classification: Orthopedic
Generic name: Prosthesis, intervertebral disc
Approval order statement: approval of an alternate manufacturing site, Summit Orthopedic Technologies Inc. (FEI 3012491394) for machining, cleaning, and passivation of the Prodisc L implants

Current openFDA PMA Record#

Device: PRODISC L
Applicant: Centinel Spine, LLC
PMA number: P050010
Supplement: S027
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2025-09-02
Decision code: APPR
Date received: 2025-06-20
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval of an alternate manufacturing site, Summit Orthopedic Technologies Inc. (FEI 3012491394) for machining, cleaning, and passivation of the Prodisc L implants