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/2021/000389_da6ca8b727c2e798a03e5d677eec23d7_885ea149216cd24231ae314e8d680029. This device is marketed under the brand name INTRAMEDULLARY NAILS. The license holder is Orthoflex Medisys (I) 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
INTRAMEDULLARY NAILS
License Holder
Orthoflex Medisys (I) Pvt. Ltd.Device Class
Approving Authority
Central Drug Standards Control Organization, Ahmedabad
Product Information
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 (INTRAMEDULLARY NAILS), and small bone (metacarpals, metatarsals, phalanges] in general. 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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