CDSCO UID IMP/MD/2018/000224_7f7e6aefdb08e44a88c70decf2b1de8d_c38e4079b482345ccc1daa90f778e6e6
Spine Implant
Stryker India Pvt. Ltd.,·Device Class Class C·India CDSCO·Brand: AVS Anchor-L Cage System
Registration details
- UID
- IMP/MD/2018/000224_7f7e6aefdb08e44a88c70decf2b1de8d_c38e4079b482345ccc1daa90f778e6e6
- Device class
- Class C
- Brand name
- AVS Anchor-L Cage System
- License holder
- Stryker India Pvt. Ltd.,
- Approving authority
- CDSCO
- Product information
- The Xia 3 Spinal System is intended for use in the non cervical spine. When used as an anterior anterolateral and posterior noncervical pedicle and nonpedicle fixation system, the Xia® 3 Spinal System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: • Degenerative Disc Disease (AVS Anchor-L Cage System) • Spondylolisthesis • Trauma (AVS Anchor-L Cage System) • Spinal stenosis • Curvatures (AVS Anchor-L Cage System) • Tumor • Pseudarthrosis • Failed previous fusion The 5.5 mm rods from the Stryker Spine Radius™ Spinal System and 6.0 mm Vitallium rods from the Xia® Spinal System are intended to be used with the other components of the Xia® 3 Spinal System. When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Xia® 3 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (AVS Anchor-L Cage System) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach
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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 IMP/MD/2018/000224_7f7e6aefdb08e44a88c70decf2b1de8d_c38e4079b482345ccc1daa90f778e6e6. This device is marketed under the brand name AVS Anchor-L Cage System. The license holder is Stryker India Pvt. Ltd.,, and it is classified as Device Class Class C. The approving authority is CDSCO.
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