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Replacement MOU for the EXOGEN® Ultrasound Bone Healing System, device identifier M937710346001.
BIOVENTUS LLC
71034601
In Commercial Distribution
- M937710346011 ()
71034601
- Bone growth ultrasonic stimulator
The EXOGEN device provides non-invasive therapy for healing non-unions and accelerating time to healing of fresh fractures. The EXOGEN Ultrasound Bone Healing Systems has been designed both for use with conservatively treated fresh fractures and non-unions or surgically treated non-unions. The device 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. The low-intensity pulsed ultrasound 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. The device automatically alerts the patient in case of improper application or device performance. The EXOGEN Ultrasound Bone Healing System consists of one main operating unit, gel bottles and strap. The main operating unit provides the treatment control circuitry, the primary battery supply, and monitors the operation of the transducer at the fracture site. The signal specifications cannot be changed.
BIOVENTUS LLC
71034600
In Commercial Distribution
- M937710346001 ()
71034600
- Bone growth ultrasonic stimulator
- Radiographic image marker, manual
- Skin topical coupling gel
- Personal device holder, single-use
Replacement Main Operating Unit (MOU) for the EXOGEN Ultrasound Bone Healing System, device identifier M937710344001.
BIOVENTUS LLC
71034401
In Commercial Distribution
- M937710344011 ()
71034401
- Bone growth ultrasonic stimulator
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 pulsed
ultrasound 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.
BIOVENTUS LLC
71034400
In Commercial Distribution
- M937710344001 ()
71034400
- Bone growth ultrasonic stimulator
- Radiographic image marker, manual
- Skin topical coupling gel
- Personal device holder, single-use
- Noninvasive device battery charger
CLS Brevius Kinectiv Rasp Size 6
Zimmer GmbH
01.00297.060
In Commercial Distribution
- 00889024487758 ()
- 6
- Bone file/rasp, manual, reusable
No Description
Zimmer GmbH
01.00296.070
In Commercial Distribution
- 00889024482555 ()
- 7
- Uncoated hip femur prosthesis, modular
No Description
Zimmer GmbH
01.00296.060
In Commercial Distribution
- 00889024482548 ()
- 6
- Uncoated hip femur prosthesis, modular
No Description
Zimmer GmbH
01.00296.200
In Commercial Distribution
- 00889024482333 ()
- 20
- Uncoated hip femur prosthesis, modular
No Description
Zimmer GmbH
01.00296.150
In Commercial Distribution
- 00889024482326 ()
- 15
- Uncoated hip femur prosthesis, modular
No Description
Zimmer GmbH
01.00296.100
In Commercial Distribution
- 00889024482319 ()
- 10
- Uncoated hip femur prosthesis, modular