PMA P070001S030
- Device
- prodisc® C
- Applicant
- Centinel Spine, LLC
- PMA number
- P070001
- Supplement
- S030
- Product code
- MJO
- Decision date
- 2026-01-15
- Classification
- Orthopedic
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- Approval for the prodisc® C Nova implant to utilize the existing prodisc® C SK superior endplate produced by the Hammill Manufacturing Company (FEI: 3000215103).
Current openFDA PMA Record#
- Device
- prodisc® C
- Applicant
- Centinel Spine, LLC
- PMA number
- P070001
- Supplement
- S030
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2026-01-15
- Decision code
- OK30
- Date received
- 2025-12-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the prodisc® C Nova implant to utilize the existing prodisc® C SK superior endplate produced by the Hammill Manufacturing Company (FEI: 3000215103).