Shoulder System - India CDSCO Medical Device Registration

Shoulder System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000110_adb7df7fd4f0b21b824d6830621ac1cc_e6c0468c6a2c461f79571c021547f1bf. This device is marketed under the brand name Non- Sterile. The license holder is M/s Zimmer India Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Shoulder System

UID: IMP/MD/2019/000110_adb7df7fd4f0b21b824d6830621ac1cc_e6c0468c6a2c461f79571c021547f1bf

Brand Name

Non- Sterile

License Holder

M/s Zimmer India Pvt. Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

This device is indicated for Reverse Application:• Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.• Fractures or avascular necrosis.• Conditions consequent to earlier operations.• Omarthrosis.• Rheumatoid arthritis.• Revision of shoulder prosthesis.• Traumatology: the only cone to be used in traumatological indications is the fracture cone

Class C

Plates for Trauma Fixation- Titanium Alloy

Brand: Non- Sterile

M/s Zimmer India Pvt. Ltd

Class C

Brand: CLS Spotorno Hip Stems

Class D