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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, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(k) Number K260796
Device Name Tahoe Unicondylar Knee System with TiNbN Overcoat
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 Number888.3520
Classification Product Code
HSX  
Date Received03/11/2026
Decision Date 04/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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