Hip Replacement System- Liners - India CDSCO Medical Device Registration

Hip Replacement System- Liners is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000140_c048184fec846e08573ab85cabf148b3_8cd889d6e749018ab0e0c3dc8264a5d1. This device is marketed under the brand name Duraloc. The license holder is Johnson & Johnson Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Hip Replacement System- Liners

UID: IMP/MD/2019/000140_c048184fec846e08573ab85cabf148b3_8cd889d6e749018ab0e0c3dc8264a5d1

Brand Name

Duraloc

License Holder

Johnson & Johnson Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. SELF-CENTERING Hip Prostheses and Hemi-Hip Prostheses are intended to be used for hemi-hip arthroplasty where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem.