PMA P070001S026

Device: prodisc - C and prodisc - C Nova (Indicated for Single Level Use)
Applicant: Centinel Spine, LLC
PMA number: P070001
Supplement: S026
Product code: MJO
Decision date: 2024-03-01
Classification: Orthopedic
Generic name: Prosthesis, intervertebral disc
Approval order statement: Approval for modification to the device labeling to include the addition of the following precaution statement: “Precaution: The safety and effectiveness of the prodisc C, when implanted at more than one cervical spinal level and/or adjacent to an anterior cervical discectomy and fusion (ACDF) has not been established.”

Current openFDA PMA Record#

Device: prodisc - C and prodisc - C Nova (Indicated for Single Level Use)
Applicant: Centinel Spine, LLC
PMA number: P070001
Supplement: S026
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2024-03-01
Decision code: APPR
Date received: 2024-02-06
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for modification to the device labeling to include the addition of the following precaution statement: “Precaution: The safety and effectiveness of the prodisc C, when implanted at more than one cervical spinal level and/or adjacent to an anterior cervical discectomy and fusion (ACDF) has not been established.”