FDA.reportPublic FDA data

EXOGEN Metatarsal Strap

Primary DI
M937710346601
Brand
EXOGEN Metatarsal Strap
Company
BIOVENTUS LLC
Model
71034660
Published
2021-12-17
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
M937710346601PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Personal device holder, single-useA patient-worn, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag, tracheostoma protector) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, strap, belt, or clothing. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18008364080ctservicescenter@bioventus.com

Regulatory Flags#

DUNS number
078450878
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00816986020099OSTEOFUSE7.5gOF0022019-02-22

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
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
00850372007240ActaStim-STHERAGEN, LLCLOF2021-02-08