Fenestrated Screw - Expedium Verse Spinal System - Non -Sterile - Ti/CoCrMo - India CDSCO Medical Device Registration
Fenestrated Screw - Expedium Verse Spinal System - Non -Sterile - Ti/CoCrMo is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000044_f4b999862f5200ccc43756a0f4cfc269_49a5fb792e6855f221ed17e997e0c579. This device is marketed under the brand name Non-Sterile. The license holder is Johnson & Johnson Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
Non-Sterile
License Holder
Johnson & Johnson Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
The EXPEDIUM VERSE Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The EXPEDIUM VERSE Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (Non-Sterile); pondylolisthesis; trauma (Non-Sterile); spinal stenosis; curvatures (Non-Sterile); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used in a posterior percutaneous approach with MIS instrumentation, the EXPEDIUM VERSE System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (Non-Sterile); spondylolisthesis; trauma (Non-Sterile); spinal stenosis; curvatures (Non-Sterile); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM VERSE System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM VERSE systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach
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