CDSCO UID MFG/MD/2021/000156_fde9bc15f028371944b79f281258c53a_a799b9d64e66bc83f477bcbc493d5aa2
BONE PLATE
Orthoflex Medisys India Pvt Ltd·Device Class Class C·India CDSCO·Brand: ORTHOFLEX MEDISYS INDIA PVT. LTD.
Registration details
- UID
- MFG/MD/2021/000156_fde9bc15f028371944b79f281258c53a_a799b9d64e66bc83f477bcbc493d5aa2
- Device class
- Class C
- Brand name
- ORTHOFLEX MEDISYS INDIA PVT. LTD.
- License holder
- Orthoflex Medisys India Pvt Ltd
- Approving authority
- Central Drug Standards Control Organization, Ahmedabad
- Product information
- Bone Plates intended to be attached to fractured long bone fragment with screw to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals. it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis.,: SPINAL IMPLANTS(ORTHOFLEX MEDISYS INDIA PVT. LTD.)-Spinal Implants are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (ORTHOFLEX MEDISYS INDIA PVT. LTD.), spinal stenosis, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors. Spinal implants are intended to be used as a temporary construct that assists normal healing and are not intended to replace normal body structures. They are intended to stabilize the spinal operative site during fusion procedures and should be removed after fusion. The IMPLANET Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The IMPLANET Spine System is intended for posterior, non-cervical pedicle and nonpedicle fixation for the following indications: degenerative disc disease (ORTHOFLEX MEDISYS INDIA PVT. LTD.), spondylolisthesis, trauma (ORTHOFLEX MEDISYS INDIA PVT. LTD.), spinal stenosis, spinal deformities (ORTHOFLEX MEDISYS INDIA PVT. LTD.), tumor, pseudarthrosis, or revision of a failed fusion attempt
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About this record
BONE PLATE is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000156_fde9bc15f028371944b79f281258c53a_a799b9d64e66bc83f477bcbc493d5aa2. This device is marketed under the brand name ORTHOFLEX MEDISYS INDIA PVT. LTD.. The license holder is Orthoflex Medisys India Pvt Ltd, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
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