PMA P250028S002
- Device
- Synergy Disc
- Applicant
- Synergy Spine Solutions, Inc.
- PMA number
- P250028
- Supplement
- S002
- Product code
- MJO
- Decision date
- 2026-07-06
- Classification
- Orthopedic
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- approval for automated polishing of the mirrored surfaces of the endplates as an alternate to manual polishing at Normal Noble
Current openFDA PMA Record#
- Device
- Synergy Disc
- Applicant
- Synergy Spine Solutions, Inc.
- PMA number
- P250028
- Supplement
- S002
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2026-07-06
- Decision code
- OK30
- Date received
- 2026-06-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for automated polishing of the mirrored surfaces of the endplates as an alternate to manual polishing at Normal Noble