PMA P900009S050
- Device
- SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S050
- Product code
- LOF
- Decision date
- 2026-03-06
- Classification
- Orthopedic
- Generic name
- Stimulator, bone growth, non-invasive
- Approval order statement
- a change in the manufacturing facility associated with the transducer cable assembly for the EXOGEN Ultrasound Bone Healing System.
Current openFDA PMA Record#
- Device
- SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A
- Applicant
- Bioventus, LLC
- PMA number
- P900009
- Supplement
- S050
- Product code
- LOF
- Generic name
- Stimulator, bone growth, non-invasive
- Decision date
- 2026-03-06
- Decision code
- OK30
- Date received
- 2026-02-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change in the manufacturing facility associated with the transducer cable assembly for the EXOGEN Ultrasound Bone Healing System.