Atlax Spacer
- UID
- PD-112_7889dd16089e8cc71cf76168b7013ccc_b45fd4ffa2cd4af673ea8efaee0f9da4
- Device class
- Class C
- Brand name
- PITKAR
- License holder
- S.H.Pitkar Orthotools Pvt. Ltd.
- Approving authority
- Central Drug Standards Control Organization, West Zone
- Product information
- The Intervertebral Fusion Device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (PITKAR) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(PITKAR). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature, and have had at least 6 months of non-operative treatment. The device is intended for use with autogenous graft, and with supplemental fixation systems cleared for use in the lumbosacral spine
Atlax Spacer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID PD-112_7889dd16089e8cc71cf76168b7013ccc_b45fd4ffa2cd4af673ea8efaee0f9da4. This device is marketed under the brand name PITKAR. The license holder is S.H.Pitkar Orthotools Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.
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