PMA P070001S021

Device: prodisc® C
Applicant: Centinel Spine, LLC
PMA number: P070001
Supplement: S021
Product code: MJO
Decision date: 2021-10-28
Generic name: Prosthesis, intervertebral disc
Approval order statement: Expand the responsibilities of Hammill Medical (360 Tomahawk Drive Maumee, OH 43537) to perform the following for the prodisc -C modified endplates (-SK, -NOVO, and -VIVO) once the modified endplates are approved: acquire the raw material, machine the endplate components, polish the superior endplates, complete inspections and bead blast the endplates.

Current openFDA PMA Record#

Device: prodisc® C
Applicant: Centinel Spine, LLC
PMA number: P070001
Supplement: S021
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2021-10-28
Decision code: OK30
Date received: 2021-09-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Expand the responsibilities of Hammill Medical (360 Tomahawk Drive Maumee, OH 43537) to perform the following for the prodisc -C modified endplates (-SK, -NOVO, and -VIVO) once the modified endplates are approved: acquire the raw material, machine the endplate components, polish the superior endplates, complete inspections and bead blast the endplates.