Vertebral Spacer
- UID
- IMP/MD/2018/000224_10a705ed1039f2fcc7b968c18821fd51_719087e5e9bfa3e1dae5421f9053b0d1
- Device class
- Class C
- Brand name
- AVS Anchor-L Cage System
- License holder
- Stryker India Pvt. Ltd.,
- Approving authority
- CDSCO
- Product information
- The Stryker Spine AVS Anchor-L is an intervertebral body fusion device indicated for use with autogenous bone graft in patients with degenerative disc disease (AVS Anchor-L Cage System) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade I spondylolisthesis at the involved level(AVS Anchor-L Cage System). These patients should be skeletally mature and have six months of nonoperative therapy. The AVSR Anchor-L Lumbar Cage system is to be implanted via an open, anterior approach. The AVSR Anchor-L Lumbar Cage system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the AVSR Anchor-L Lumbar Cage must be used with the internal screw and plate fixation provided by AVSR Anchor-L Fixation Screws and Locking Plate. If AVSR Anchor-L is used with less than three or none of the provided screws, then additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine must be used to augment stability. The accompanying Locking Plate must be used anytime the device is used with any number of screws
Vertebral Spacer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000224_10a705ed1039f2fcc7b968c18821fd51_719087e5e9bfa3e1dae5421f9053b0d1. 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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