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Elbow joint metal/ polymer constrained cemented prosthesis - India CDSCO Medical Device Registration

Elbow joint metal/ polymer constrained cemented prosthesis is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000212_c95e641867edde6ff59f58a8f6c8e90f_41300850259b3566f25087d2ab9dde03. This device is marketed under the brand name "DDD". The license holder is Onyx Medicals Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.

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CDSCO Registered
Class Class C
Elbow joint metal/ polymer constrained cemented prosthesis
UID: MFG/MD/2020/000212_c95e641867edde6ff59f58a8f6c8e90f_41300850259b3566f25087d2ab9dde03

Brand Name

"DDD"

Device Class

Class C

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

It may be used as a replacement of radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint. Primary replacement after fracture of radial head, symptomatic sequelae after radial head resection, revision following failed radial head artroplasty.

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