Address:1900 Charles Bryan Rd Suite 275,Cordova,TN,38016,US
Device Description : Bioactive Bone Graft Putty
Device Class : 2
Duns Number: 078450878
Premarket Exempt : No
Prescription Use : Yes
Device Description : Bioactive Bone Graft Putty
Device Class : 2
Duns Number: 078450878
Premarket Exempt : No
Prescription Use : Yes
Device Description : SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising b SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
Device Class : 2
Duns Number: 078450878
Premarket Exempt : No
Prescription Use : Yes
Device Description : SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising b SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
Device Class : 2
Duns Number: 078450878
Premarket Exempt : No
Prescription Use : Yes
Device Description : SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising b SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
Device Class : 2
Duns Number: 078450878
Premarket Exempt : No
Prescription Use : Yes
Device Description : SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising b SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
Device Class : 2
Duns Number: 078450878
Premarket Exempt : No
Prescription Use : Yes
Device Description : DUROLANE is a clear, transparent, viscous gel of highly purified, stabilized, no DUROLANE is a clear, transparent, viscous gel of highly purified, stabilized, non-animal-derived sodium hyaluronate that is biosynthesized using bacterial fermentation. NASHA® technology is used to stabilize naturally entangled hyaluronic acid (HA) chains to produce a gel. The gel is suspended in phosphate-buffered saline at a concentration of 20 mg/mL. DUROLANE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacological therapy or simple analgesics, e.g. acetaminophen.
Device Class :
Duns Number: 078450878
Premarket Exempt : No
Prescription Use : Yes
Device Description : The EXOGEN Ultrasound Bone Healing System provides non-invasive therapy for heal 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.
Device Class : 3
Duns Number: 078450878
Premarket Exempt : No
Prescription Use : Yes
Device Description : Replacement Main Operating Unit (MOU) for the EXOGEN Ultrasound Bone Healing Sys Replacement Main Operating Unit (MOU) for the EXOGEN Ultrasound Bone Healing System, device identifier M937710344001.
Device Class : 3
Duns Number: 078450878
Premarket Exempt : No
Prescription Use : Yes
Device Description : The EXOGEN device provides non-invasive therapy for healing non-unions and accel 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.
Device Class : 3
Duns Number: 078450878
Premarket Exempt : No
Prescription Use : Yes