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CDSCO UID MFG/MD/2021/000347_7886e69360a8f7e578a813167a8a7bdf_edd038283e773a990230eff5fa95db3d

Orthopedic Spinal Implant - Stainless Steel

Ortho Care·Device Class Class C·India CDSCO·Brand: CARE, ACE, FRAGMENT, AOCARE, AIMEN
Registration details
UID
MFG/MD/2021/000347_7886e69360a8f7e578a813167a8a7bdf_edd038283e773a990230eff5fa95db3d
Device class
Class C
Brand name
CARE, ACE, FRAGMENT, AOCARE, AIMEN
License holder
Ortho Care
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. Drummer’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 Drummer’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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Products from the same license holder (10 products)
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Brand: CARE, ACE, FRAGMENT, AOCARE, AIMEN
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About this record

Orthopedic Spinal Implant - Stainless Steel is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000347_7886e69360a8f7e578a813167a8a7bdf_edd038283e773a990230eff5fa95db3d. This device is marketed under the brand name CARE, ACE, FRAGMENT, AOCARE, AIMEN. The license holder is Ortho Care, and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.

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