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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 K252846
Device Name TaperSet™ Hip System
Applicant
Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics
1115 Windfield Way
El Dorado Hills,  CA  95762
Applicant Contact Romil Sheth
Correspondent
Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics
1115 Windfield Way
El Dorado Hills,  CA  95762
Correspondent Contact Romil Sheth
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   LZO   OQG   OQI  
Date Received09/08/2025
Decision Date 11/20/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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