Spine Implant - India CDSCO Medical Device Registration

Spine Implant is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000274_7f7e6aefdb08e44a88c70decf2b1de8d_c0675a40d00b584bed0b40811b5509d0. This device is marketed under the brand name HARDIK / ORTHOX. The license holder is Hardik International Private Limited, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class C

Spine Implant

UID: MFG/MD/2020/000274_7f7e6aefdb08e44a88c70decf2b1de8d_c0675a40d00b584bed0b40811b5509d0

Brand Name

HARDIK / ORTHOX

License Holder

Hardik International Private Limited

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Spinal system consists of a variety of shapes and sizes of rods, screw, transverse link as well as cages and cervical implants. Screw is intended for internal fixation of fractures and reconstruction of spinal bones, and for scoliosis. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions. Different sizes are available with different design for better alignment an as per fracture

Class C

Spine Implant

Brand: AVS Anchor-L Cage System

Stryker India Pvt. Ltd.,

Class C

Brand: HARDIK / ORTHOX

Class C