PMA P250028S003
- Device
- Synergy Disc
- Applicant
- Synergy Spine Solutions, Inc.
- PMA number
- P250028
- Supplement
- S003
- Product code
- MJO
- Decision date
- 2026-09-17
- Classification
- Orthopedic
- Generic name
- Prosthesis, intervertebral disc
- Approval order statement
- packaging materials changes and the addition of a secondary packaging configuration
Current openFDA PMA Record#
- Device
- Synergy Disc
- Applicant
- Synergy Spine Solutions, Inc.
- PMA number
- P250028
- Supplement
- S003
- Product code
- MJO
- Generic name
- Prosthesis, intervertebral disc
- Decision date
- 2026-09-17
- Decision code
- APPR
- Date received
- 2026-06-25
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- packaging materials changes and the addition of a secondary packaging configuration