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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/2019/000029_c048184fec846e08573ab85cabf148b3_9d985bb85f80a2b8b419bc667fdfc31a. This device is marketed under the brand name LPS. 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/2019/000029_c048184fec846e08573ab85cabf148b3_9d985bb85f80a2b8b419bc667fdfc31a

Brand Name

LPS

Device Class

Class D

Approving Authority

CDSCO

Product Information

It is intended for Total Hip Prostheses, Hemi-Hip Prostheses, and Self-Centering Hip Prostheses. 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. The Pinnacle Constrained Acetabular Liner is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability. The Pinnacleยฎ Constrained Acetabular Liner is indicated for use with the Pinnacleยฎ Acetabular Cup in cementless application

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