Atlax Spacer - India CDSCO Medical Device Registration

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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered

Class Class C

Atlax Spacer

UID: PD-112_7889dd16089e8cc71cf76168b7013ccc_b45fd4ffa2cd4af673ea8efaee0f9da4

Brand Name

PITKAR

License Holder

S.H.Pitkar Orthotools Pvt. Ltd.

Device Class

Class C

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

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Atlax Plate

Brand: PITKAR

S.H.Pitkar Orthotools Pvt. Ltd.

Atlax Spacer - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

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Atlax Screw

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