Bone Plate - India CDSCO Medical Device Registration

Bone Plate is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000248_3d18736f7e1d94ec1c52f33e2e890dda_3075b0d98e084c61434a66e0797ea095. This device is marketed under the brand name AOSYS. The license holder is M/s AOSYS PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class C

Bone Plate

UID: MFG/MD/2022/000248_3d18736f7e1d94ec1c52f33e2e890dda_3075b0d98e084c61434a66e0797ea095

Brand Name

AOSYS

License Holder

M/s AOSYS PRIVATE LIMITED

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

The implants will be used for selected fractures elsewhere in the body so long as medically indicated and bone mass compatible. Bone Plates is intended for implantation into prepared bone during orthopaedic surgery when the surgeon determines the need for additional fixation: bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device

Class B

Bone Plate

Narang Medical Corporation

Class C

Brand: AOSYS

Class C

Bone Screw

Brand: AOSYS

Class C