FDA.reportPublic FDA data

EXOGEN® Ultrasound Bone Healing System MOU

Primary DI
M937710344011
Brand
EXOGEN® Ultrasound Bone Healing System MOU
Company
BIOVENTUS LLC
Model
71034401
Catalog number
71034401
Device description
Replacement Main Operating Unit (MOU) for the EXOGEN Ultrasound Bone Healing System, device identifier M937710344001.
Published
2017-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LOFStimulator, Bone Growth, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOFStimulator, Bone Growth, Non-InvasiveUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P900009035

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P900009035SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2ABioventus, LLC1994-10-05LOF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M937710344011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone growth ultrasonic stimulatorA mains electricity (AC-powered) device designed to accelerate bone formation (osteogenesis) through the application of ultrasound energy. It typically consists of a pulsed low-intensity ultrasound generator that includes a transducer probe and a retaining and alignment fixture for the probe. The device is typically used to promote healing of nonunion fractures; it is also used to speed the healing of fresh fractures.

Contacts#

Phone, Email table
PhoneEmail
1-800-836-4080CTServicesCenter@bioventusglobal.com

Regulatory Flags#

DUNS number
078450878
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M937710346601EXOGEN Metatarsal Strap710346602021-12-17
M937710344001EXOGEN® Ultrasound Bone Healing System71034400710344002017-01-12
M937710346001EXOGEN® Ultrasound Bone Healing System71034600710346002017-01-12
00816986020549TalisMann Implant KitTM-10002025-09-01
00816986020556StimTrial Surgical KitTS-10002025-09-01
00816986020570StimTrial Patient KitTS-60002025-09-01
00816986020587StimTrial Stimulator KitTS-50002025-09-01
00816986020617Bioventus User KitPNS-50002025-09-01
00816986020624Bioventus Clinician KitPNS-10002025-09-01
10389130444418SUPARTZ FX sodium hyaluronate715644442023-09-28
00816986020525Osteoamp Flowable Access CannulaOFAC-COFAC-C2024-11-21
00816986020037INTERFACEIFBG100IFBG1002019-05-06
00816986020488SIGNAFUSE Bioactive Bone Graft25X25X8 MM, 5 CCSGFS-0052020-07-30
00816986020495SIGNAFUSE Bioactive Bone Graft50X25X8 MM, 10 CCSGFS-0102020-07-30
00816986020501SIGNAFUSE Bioactive Bone Graft100X25X8 MM, 20 CCSGFS-0202020-07-30
00816986020518SIGNAFUSE Bioactive Bone Graft200X25X8 MM, 40 CCSGFS-0402020-07-30
00816986020006SIGNAFUSE15gSGF-1502019-02-22
00816986020013SIGNAFUSE7.5gSGF-0752019-02-22
00816986020020SIGNAFUSE3.75gSGF-0372019-02-22
00816986020082OSTEOFUSE3.75gOF0012019-02-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850047248107XstimXstim, IncLOF2026-04-08
00850047248008XstimXstim, IncLOF2024-08-16
10850047248005XstimXstim, IncLOF2024-08-16
00850047248015XstimXstim, IncLOF2024-08-16
00850047248022XstimXstim, IncLOF2024-08-16
00850047248039XstimXstim, IncLOF2024-08-16
00850047248046XstimXstim, IncLOF2024-08-16
00850047248053XstimXstim, IncLOF2024-08-16
00850047248060XstimXstim, IncLOF2024-08-16
00850047248077XstimXstim, IncLOF2024-08-16
00850047248084XstimXstim, IncLOF2024-08-16
00850047248091XstimXstim, IncLOF2024-08-16
18257200158706AccelStimOrthofix US LLCLOF2023-06-12
18257200158713AccelStimOrthofix US LLCLOF2023-06-12
18257200158720AccelStimOrthofix US LLCLOF2023-06-12
08050040997336AccelstimIGEA SPALOF2022-11-04
08050040997299AccelstimIGEA SPALOF2022-08-30
08050040997305AccelstimIGEA SPALOF2022-08-30
08050040997312AccelstimIGEA SPALOF2022-08-30
08050040997329AccelstimIGEA SPALOF2022-08-30
08050040997213AccelStimIGEA SPALOF2022-07-14
M937710346601EXOGEN Metatarsal StrapBIOVENTUS LLCLOF2021-12-17
00850372007165ActaStim-S THERAGEN, LLCLOF2021-02-08
00850372007172ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007189ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007196ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007202ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007219ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007226ActaStim-STHERAGEN, LLCLOF2021-02-08
00850372007233ActaStim-STHERAGEN, LLCLOF2021-02-08