EXOGEN® Ultrasound Bone Healing System

Primary DI
M937710344001
Brand
EXOGEN® Ultrasound Bone Healing System
Company
BIOVENTUS LLC
Model
71034400
Catalog number
71034400
Device description
The EXOGEN Ultrasound Bone Healing System provides non-invasive therapy for healing non-unions and accelerating time to healing of fresh fractures. EXOGEN is designed both for use with conservatively treated fresh fractures and non-unions, or surgically-treated non-unions. EXOGEN transmits a low-intensity ultrasound signal to the fracture site through coupling gel, with little or no sensation felt by the patient during the treatment. Low-intensity pulsedultrasound has been shown in in-vitro and in-vivo studies to stimulate cells to produce growth factors and proteins that are important to bone healing.The patient administers treatment at home or at work, once daily, for 20 minutes, or as prescribed by a physician. EXOGEN automatically alerts the patient in case of improper application or performance. The EXOGEN Ultrasound Bone Healing System consists of one EXOGEN device, a charger, a gel bottle and strap. The EXOGEN device provides the treatment control circuitry, the battery supply and monitors the operation of the transducer at the fracture site. Thesignal specifications cannot be changed.
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
M937710344001PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure700 millibar1060 millibar
Handling Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius32 Degrees Celsius
Storage Environment Atmospheric Pressure700 millibar1060 millibar
Storage Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius32 Degrees Celsius

Sterilization Methods#

Method table
Method

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

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Primary DI, Brand, Model table
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M937710346001EXOGEN® Ultrasound Bone Healing System71034600710346002017-01-12
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00816986020495SIGNAFUSE Bioactive Bone Graft50X25X8 MM, 10 CCSGFS-0102020-07-30
00816986020501SIGNAFUSE Bioactive Bone Graft100X25X8 MM, 20 CCSGFS-0202020-07-30
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00816986020006SIGNAFUSE15gSGF-1502019-02-22
00816986020013SIGNAFUSE7.5gSGF-0752019-02-22
00816986020020SIGNAFUSE3.75gSGF-0372019-02-22
00816986020082OSTEOFUSE3.75gOF0012019-02-22
00816986020099OSTEOFUSE7.5gOF0022019-02-22

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