Orthopedic Bone screws and washers -Titanium - India CDSCO Medical Device Registration

Orthopedic Bone screws and washers -Titanium is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000089_513d28354e5dee7c3f9a096b4139bf47_cf99c225593e7ba6921a2913b97a926a. This device is marketed under the brand name CARE, ACE, FRAGMENT, AOCARE, AIMEN. The license holder is Shriram Institute For Industrial Research, 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

Orthopedic Bone screws and washers -Titanium

UID: MFG/MD/2022/000089_513d28354e5dee7c3f9a096b4139bf47_cf99c225593e7ba6921a2913b97a926a

Brand Name

CARE, ACE, FRAGMENT, AOCARE, AIMEN

License Holder

Shriram Institute For Industrial Research

Device Class

Class C

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

Bone Screws when used in combination with plates are intended for fixation of various fractures, osteotomies, malunions, arthrodesis, replacement, reconstruction, correction, stabilization of various bones [clavicle, pelvis, scapula, long bone (CARE, ACE, FRAGMENT, AOCARE, AIMEN), and small bone (metacarpals, metatarsals, phalanges] in general. The Bone washers 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.