BONE SCREW - India CDSCO Medical Device Registration
BONE SCREW is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000156_da6ca8b727c2e798a03e5d677eec23d7_4765c97cc22029dc41086ff1b91c148c. This device is marketed under the brand name ORTHOFLEX MEDISYS INDIA PVT. LTD.. The license holder is Orthoflex Medisys India Pvt Ltd, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
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Brand Name
ORTHOFLEX MEDISYS INDIA PVT. LTD.
License Holder
Orthoflex Medisys India Pvt LtdDevice Class
Approving Authority
Central Drug Standards Control Organization, Ahmedabad
Product Information
ORTHOFLEX MEDISYS (ORTHOFLEX MEDISYS INDIA PVT. LTD.) PVT. LTD.’s Bone Screws when used in combination with plates are intended for fixation of various fractures, osteotomies, malunions, replacement, reconstruction, correction, stabilization of various bones [clavicle, pelvis, scapula, long bone (ORTHOFLEX MEDISYS INDIA PVT. LTD.), and small bone (metacarpals, metatarsals, phalanges] in general. The ORTHOFLEX MEDISYS (ORTHOFLEX MEDISYS INDIA PVT. LTD.) PVT. LTD.’s Bone washer are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of large bone and bone fragments
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