Spine Implant - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class C

Spine Implant

UID: MFG/MD/2020/000300_7f7e6aefdb08e44a88c70decf2b1de8d_9f741a0613fd16648ef891379ca0fbc6

Brand Name

SOLCO

License Holder

SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED

Device Class

Class C

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

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Visualization system for arthroscopic and endoscopic procedure

Brand: SOLCO

SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED

Spine Implant - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Visualization system for arthroscopic and endoscopic procedure

Surgical Mallet

Depth Gauge

Reamer & its attachment

Retractor Holder

Bone Tap

Surgical Trays

Dilator & accessories

Orthopaedic implant impactor

Torque Wrench

Visualization system for arthroscopic and endoscopic procedure

Surgical Mallet

Depth Gauge

Reamer & its attachment

Retractor Holder

Bone Tap

Surgical Trays

Dilator & accessories