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/2019/000061_34f5cf5637c17f0474ebe7d8d7cfcaeb_877f1b2610bcb61458a3a86c390f2644. This device is marketed under the brand name Fix/Mobile/Revision System And Tumor System. The license holder is SMIT MEDIMED 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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CDSCO Registered

Class Class C

Bone Screw

UID: MFG/MD/2019/000061_34f5cf5637c17f0474ebe7d8d7cfcaeb_877f1b2610bcb61458a3a86c390f2644

Brand Name

Fix/Mobile/Revision System And Tumor System

License Holder

SMIT MEDIMED PVT LTD

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

The bone screw is intended to use for internal fixation of bone fractures and reconstruction of bones, there are several types of screw like locking head screw, general cortical screw or Leg screw of DHS (Fix/Mobile/Revision System And Tumor System) are used for fixing of Bone plate, nail, DHS plate, locking plates which is used for osteotomy patients Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for ventral, dorsal or orthogonal applications

Class C

Bone Screw

Brand: SSPL

SONY SURGICAL PVT. LTD.

Class C

Brand: SMPL

Class A