CDSCO UID MFG/MD/2022/000516_dd6212d43c17f890be58dc96c0b8b85a_42b1de0c44c086821c53855793d8a834
Spinal cage system instruments
Auxein Medical Private Limited·Device Class Class A·India CDSCO
Registration details
- UID
- MFG/MD/2022/000516_dd6212d43c17f890be58dc96c0b8b85a_42b1de0c44c086821c53855793d8a834
- Device class
- Class A
- License holder
- Auxein Medical Private Limited
- Approving authority
- Haryana
- Product information
- The spinal cage system instruments are used by surgeon for spinal implants, devices or hardware, 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, 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. The system does not include orthopaedic implants. These instruments are use with implant and indicated for use in posterior lumbar interbody fiusion or transforminal interbody fusion in patients with Degenerative Disc Disease ##PLACEHOLDER_0## at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the lumbar Cage is indicated to assist in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis
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About this record
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_42b1de0c44c086821c53855793d8a834. 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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