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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K222816
Device Name Opulent TiNbN Coated Knee
Applicant
Meril Healthcare Pvt. , Ltd.
Survey # 135/2/B & 174/2, H1-H3 , Meril Park,
Muktanand Marg, Chala
Vapi,  IN 396191
Applicant Contact Neelam Desai
Correspondent
Meril Healthcare Pvt. , Ltd.
Survey # 135/2/B & 174/2, H1-H3 , Meril Park,
Muktanand Marg, Chala
Vapi,  IN 396191
Correspondent Contact Neelam Desai
Regulation Number888.3560
Classification Product Code
JWH  
Date Received09/19/2022
Decision Date 11/18/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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