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Spinal cage system instruments - India CDSCO Medical Device Registration

Spinal cage system instruments is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000516_dd6212d43c17f890be58dc96c0b8b85a_8333d8374136841de8644c3fa4d7e445. The license holder is Auxein Medical Private Limited, and it is classified as Device Class Class A. The approving authority is Haryana.

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CDSCO Registered
Class Class A
Spinal cage system instruments
UID: MFG/MD/2022/000516_dd6212d43c17f890be58dc96c0b8b85a_8333d8374136841de8644c3fa4d7e445

Device Class

Class A

Approving Authority

Haryana

Product Information

The spinal cage system instruments are used by surgeon for spinal implants, devices , uses surgical procedures to implant titanium, titanium- alloy, stainless steel, or non-metallic devices into the spine. The instrument set includes rasp for cervical disc spacer, bone graft compactor, bone tamp for cervical disc spacer, cage support block,trial, cervical distractor pin, cutter for cage, funnel, graft, seat holder for cervical disc spacer, introducer for cervical disc spacer, left angled curette, quick change, quick change for box chisel, spreader, tap handle - quick coupling, threaded inserter for droner peek cage, tlif cage guide, tlif cage holder, tommy bar for cages, trial for droner peek/plif /radial tlif cage, Cervical Distractor, Rasp For Radial Tlif/Plif Cage, Right Angled Curette, Screw Tighter, Pin Introducer For Vertebral Distractor, Plif Cage Holder, Dura, Curette Torque Limiting Attachment Awl Drill Bit With Stop . The system does not include orthopaedic implants.The Cervical Cage instruments are intended to replace cervical intervertebral discs and to fuse adjacent vertebral bodies at vertebral levels C2 โ€“ C7 following anterior cervical discectomy for reduction and stabilization of the cervical spine. The use of autologous bone or bone graft substitute is recommended. Indications Cervical pathologies for which segmental arthrodesis is indicated: Degenerative disc diseases and instabilities Ruptured and herniated discs Pseudarthrosis or failed spondylodesis. For multisegmental fusions with the ACDF system supplemental fixation is recommended

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