Cage with plate - India CDSCO Medical Device Registration
Cage with plate is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID PD-112_eee12f26821889d361811b9bf5e9a610_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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Brand Name
PITKAR
License Holder
S.H.Pitkar Orthotools Pvt. Ltd.Device Class
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 Plate
Brand: PITKAR
S.H.Pitkar Orthotools Pvt. Ltd.
Abutment
Brand: PITKAR
S.H.Pitkar Orthotools Pvt. Ltd.
Jupiter Head
Brand: PITKAR
S.H.Pitkar Orthotools Pvt. Ltd.
Abutment Screw
Brand: PITKAR
S.H.Pitkar Orthotools Pvt. Ltd.
Atlax Screw
Brand: PITKAR
S.H.Pitkar Orthotools Pvt. Ltd.
Atlax Spacer
Brand: PITKAR
S.H.Pitkar Orthotools Pvt. Ltd.
Slim Abutment
Brand: PITKAR
S.H.Pitkar Orthotools Pvt. Ltd.
Hybrid adjustable Cages
Brand: PITKAR
S.H.Pitkar Orthotools Pvt. Ltd.
Saturn Bipolar Cup
Brand: PITKAR
S.H.Pitkar Orthotools Pvt. Ltd.
Titax Cranial Mesh
Brand: PITKAR
S.H.Pitkar Orthotools Pvt. Ltd.
Atlax Plate
Brand: PITKAR
Abutment
Brand: PITKAR
Jupiter Head
Brand: PITKAR
Abutment Screw
Brand: PITKAR
Atlax Screw
Brand: PITKAR
Atlax Spacer
Brand: PITKAR
Slim Abutment
Brand: PITKAR
Hybrid adjustable Cages
Brand: PITKAR
Saturn Bipolar Cup
Brand: PITKAR
Titax Cranial Mesh
Brand: PITKAR