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Orthopedic Spinal Implant - Titanium - India CDSCO Medical Device Registration

Orthopedic Spinal Implant - Titanium is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000089_a428d3bb145061343fd05d6e06d10b6e_edd038283e773a990230eff5fa95db3d. This device is marketed under the brand name CARE, ACE, FRAGMENT, AOCARE, AIMEN. The license holder is Shriram Institute For Industrial Research, and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.

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CDSCO Registered
Class Class C
Orthopedic Spinal Implant - Titanium
UID: MFG/MD/2022/000089_a428d3bb145061343fd05d6e06d10b6e_edd038283e773a990230eff5fa95db3d

Brand Name

CARE, ACE, FRAGMENT, AOCARE, AIMEN

Device Class

Class C

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

Anterior Cervical Plate and Screw: The Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthosis as a result of previously failed cervical spine surgery; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy Monoaxial Screws and Hooks with spinal rods: The monoaxial screws and hook system are intended for use a posterior pedicle screw fixation system (CARE, ACE, FRAGMENT, AOCARE, AIMEN) or posterior hook fixation system (CARE, ACE, FRAGMENT, AOCARE, AIMEN) or as an anterolateral fixation system (CARE, ACE, FRAGMENT, AOCARE, AIMEN). These devices are intended for all the below: Degenerative Disc Disease, Spondylolisthesis, trauma, deformities or curvatures, stenosis, pseudoarthrosis and failed previous fusion. Polyaxial Screws with Spinal Rods: The polyaxial screw and rod system are intended for providing segmental stabilization of the spine in skeletally mature patients. Drummerโ€™s wire Intended Use / Application: These wires are generally used in spine fractures along with Hart Shells. Hart shell Intended Use / Application: Hart Shall are generally used in spine fractures along with Drummerโ€™s Wires. Harrington rod & hooks Intended Use / Application: Harrington Rods are used in spinal surgery. Harrington Rod is used along with Harrington Hooks in spinal fractures

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