CDSCO UID MFG/MD/2020/000300_7f7e6aefdb08e44a88c70decf2b1de8d_9f741a0613fd16648ef891379ca0fbc6

Spine Implant

SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED·Device Class Class C·India CDSCO·Brand: SOLCO
Registration details
UID
MFG/MD/2020/000300_7f7e6aefdb08e44a88c70decf2b1de8d_9f741a0613fd16648ef891379ca0fbc6
Device class
Class C
Brand name
SOLCO
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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Products from the same license holder (10 products)
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Surgical Mallet
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Reamer & its attachment
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Retractor Holder
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Gun Type Persuader , I type Persauder , Reduction Tower, Screw Compressor , Compressor , Single Action Compressor , Double Action Compressor, Screw Distractor, Distractor , Single Action Distractor , Double Action Distractor , Reduction Head Cutter , Head Breaker , Reduction Tab Remover, Driver , Hex / Star / Any other Profile which can be fit with Spine Instruments , Cross Link Screw Driver / Transverse Link Driver , Implants Container , Implant Box / Graphical Container , Instruments Container / Graphical Instrument Container / Instrument Box , In
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Gun Type Persuader , I type Persauder , Reduction Tower, Screw Compressor , Compressor , Single Action Compressor , Double Action Compressor, Screw Distractor, Distractor , Single Action Distractor , Double Action Distractor , Reduction Head Cutter , Head Breaker , Reduction Tab Remover, Driver , Hex / Star / Any other Profile which can be fit with Spine Instruments , Cross Link Screw Driver / Transverse Link Driver , Implants Container , Implant Box / Graphical Container , Instruments Container / Graphical Instrument Container / Instrument Box , In
Class A
Bone Tap
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Surgical Trays
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Dilator & accessories
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About this record

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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