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_5b2927a2c71a835809f9617e9a742237. 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_5b2927a2c71a835809f9617e9a742237

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 Hemiarthroplasty/ Total application: • The Anatomical Shoulder Inverse/Reverse System is indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.• The patient’s joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device

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