Address:4234 Hacienda Dr. Suite 150,Pleasanton,CA,94588,US
Device Description : The DTRAX Cervical Cage-B is a single-use, titanium alloy intervertebral implant The DTRAX Cervical Cage-B is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It is intended to be used in cervical spinal fusion surgery for skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level.
Device Class : 2
Duns Number: 969820245
Premarket Exempt : No
Prescription Use : Yes
Device Description : The CAVUX Cervical Cage-T is a single-use, titanium alloy intervertebral implant The CAVUX Cervical Cage-T is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It is intended to be used in cervical spinal fusion surgery for skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level.
Device Class : 2
Duns Number: 969820245
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ALLY Bone Screw is a single-use implant made of titanium alloy and used in b The ALLY Bone Screw is a single-use implant made of titanium alloy and used in bone reconstruction, osteotomy, arthrodesis, join fusion, fracture repair and fixation appropriate for the size of the device.
Device Class : 2
Duns Number: 969820245
Premarket Exempt : No
Prescription Use : Yes
Device Description : The DTRAX® Spinal System is a set of instruments intended and indicated for acce The DTRAX® Spinal System is a set of instruments intended and indicated for access and preparation of a spinal joint to aid in fusion.
Device Class : 2
Duns Number: 969820245
Premarket Exempt : No
Prescription Use : Yes
Device Description : A set of individual non-powered, disposable, hand-held surgical instruments inte A set of individual non-powered, disposable, hand-held surgical instruments intended and indicated for preparation of a spinal joint to aid in fusion. The set contains trial spacers, an awl, and a screwdriver.
Device Class : 1
Duns Number: 969820245
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : CAVUXTM Cervical Cage is indicated for use in skeletally mature patients with de CAVUXTM Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
Device Class : 2
Duns Number: 969820245
Premarket Exempt : No
Prescription Use : Yes
Device Description : CAVUX Cervical Cage is indicated for use in skeletally mature patients with dege CAVUX Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
Device Class : 2
Duns Number: 969820245
Premarket Exempt : No
Prescription Use : Yes
Device Description : CAVUXTM Cervical Cage is indicated for use in skeletally mature patients with de CAVUXTM Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
Device Class : 2
Duns Number: 969820245
Premarket Exempt : No
Prescription Use : Yes
Device Description : CAVUX Cervical Cage is indicated for use in skeletally mature patients with dege CAVUX Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
Device Class : 2
Duns Number: 969820245
Premarket Exempt : No
Prescription Use : Yes
Device Description : CAVUXTM Cervical Cage is indicated for use in skeletally mature patients with de CAVUXTM Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
Device Class : 2
Duns Number: 969820245
Premarket Exempt : No
Prescription Use : Yes