CDSCO UID MFG/MD/2020/000080_824a29e2188d836c1ea153f79c0c894b_50b83b5c0ca7953459428dd8b4f87b55

Spinal Implant

GREENS SURGICALS (P) LTD.·Device Class Class C·India CDSCO

Registration details

UID: MFG/MD/2020/000080_824a29e2188d836c1ea153f79c0c894b_50b83b5c0ca7953459428dd8b4f87b55
Device class: Class C
License holder: GREENS SURGICALS (P) LTD.
Approving authority: Central Drug Standards Control Organization, Ahmedabad
Product information: Titanium alloy ##PLACEHOLDER_0## Grade 5##PLACEHOLDER_0##-: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 ##PLACEHOLDER_0## or posterior hook fixation system ##PLACEHOLDER_0## or as an anterolateral fixation system ##PLACEHOLDER_0##. 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