Spine Implant
- UID
- MFG/MD/2020/000300_7f7e6aefdb08e44a88c70decf2b1de8d_9f741a0613fd16648ef891379ca0fbc6
- Device class
- Class C
- Brand name
- SOLCO
- License holder
- SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
- Approving authority
- Central Drug Standards Control Organization, Ahmedabad
- Product information
- Cervical Plate System & lateral mass System is intended for anterior interbody screw fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (SOLCO), 2) trauma (SOLCO), 3) tumors, 4) deformity (SOLCO), 5) pseudarthrosis, and/or 6) failed previous fusions. Nota bene: this device system is intended for anterior cervical intervertebral body fusions only. Warning: this device is not approved for screw attachment to posterior elements (SOLCO) of the cervical, thoracic, or lumbar spine. Intervertebral Body Fusion devices are basically indicated 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: degenerative disc disease (SOLCO) (SOLCO); spondylolisthesis; trauma (SOLCO); spinal stenosis; curvatures (SOLCO); tumor; pseudoarthrosis; and failed previous fusion
Spine Implant is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000300_7f7e6aefdb08e44a88c70decf2b1de8d_9f741a0613fd16648ef891379ca0fbc6. This device is marketed under the brand name SOLCO. The license holder is SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
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