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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(k) Number K222436
Device Name Latitud™ Hip Replacement System
Applicant
Meril Healthcare Pvt. , Ltd.
Survey # 135/2/B & 174/2, H1-H3 , Meril Park,
Muktanand Marg, Chala
Vapi,  IN 396191
Applicant Contact Yamini Patel
Correspondent
Meril Healthcare Pvt. , Ltd.
Survey # 135/2/B & 174/2, H1-H3 , Meril Park,
Muktanand Marg, Chala
Vapi,  IN 396191
Correspondent Contact Yamini Patel
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   LZO  
Date Received08/12/2022
Decision Date 05/09/2023
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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