CDSCO UID MFG/MD/2020/000078_4fa0dc7bd0f26a0cec29f7e69a03c8a1_76eab455bd5aafb75fedd686257971dd

Spinal Implants

Krenila Ortho·Device Class Class C·India CDSCO·Brand: Krenila
Registration details
UID
MFG/MD/2020/000078_4fa0dc7bd0f26a0cec29f7e69a03c8a1_76eab455bd5aafb75fedd686257971dd
Device class
Class C
Brand name
Krenila
License holder
Krenila Ortho
Approving authority
Central Drug Standards Control Organization, Ahmedabad
Product information
The krenila Spine System is a posterior pedicle screw and hook fixation system .intended to provide precise and segmental stabilization of the spine for use in skeletally mature patients. It is an instrument set designed for insertion of cannulated KRENILA pedicle screws and rods through a percutaneous or mini-open muscle sparing approach. The KRENILA perforated screws are an addition to the KRENILA System, a posterior pedicle screw and hook fixation system intended to provide precise and segmental stabilization of the spine in skeletally mature patients. KRENILA perforated pedicle screws may be inserted traditionally as solid KRENILA screws and with Kirschner wire guidance as KRENILA cannulated screws including a minimally invasive approach with KRENILA. KRENILA perforated screws direct Vertecem V+ through lateral perforations to augment the pedicle screw in the vertebral body. Augmentation of pedicle screws with cement increases pedicle screw anchoring in vertebral bone, especially in cases of diminished bone quality
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About this record

Spinal Implants is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000078_4fa0dc7bd0f26a0cec29f7e69a03c8a1_76eab455bd5aafb75fedd686257971dd. This device is marketed under the brand name Krenila. The license holder is Krenila Ortho, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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