Opulent TiNbN Coated Knee

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

Meril Healthcare Pvt. Ltd.

The following data is part of a premarket notification filed by Meril Healthcare Pvt. Ltd. with the FDA for Opulent Tinbn Coated Knee.

Pre-market Notification Details

Device IDK222816
510k NumberK222816
Device Name:Opulent TiNbN Coated Knee
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant Meril Healthcare Pvt. Ltd. Survey No. 135/2/B & 174/2, H1-H3 , Meril Park Muktanand Marg, Chala Vapi,  IN 396191
ContactNeelam Desai
CorrespondentNeelam Desai
Meril Healthcare Pvt. Ltd. Survey No. 135/2/B & 174/2, H1-H3 , Meril Park Muktanand Marg, Chala Vapi,  IN 396191
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-09-19
Decision Date2022-11-18

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