PMA P900009S049

Device: EXOGEN® Ultrasound Bone Healing System
Applicant: Bioventus, LLC
PMA number: P900009
Supplement: S049
Product code: LOF
Decision date: 2023-12-21
Classification: Orthopedic
Generic name: Stimulator, bone growth, non-invasive
Approval order statement: Approval for an additional manufacturing site (Bioventus LLC, Cordova, Tennessee, FEI # 302669735) for the EXOGEN Ultrasound Bone Healing System.

Current openFDA PMA Record#

Device: EXOGEN® Ultrasound Bone Healing System
Applicant: Bioventus, LLC
PMA number: P900009
Supplement: S049
Product code: LOF
Generic name: Stimulator, bone growth, non-invasive
Decision date: 2023-12-21
Decision code: APPR
Date received: 2023-07-20
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for an additional manufacturing site (Bioventus LLC, Cordova, Tennessee, FEI # 302669735) for the EXOGEN Ultrasound Bone Healing System.