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510(k) K260796

Tahoe Unicondylar Knee System with TiNbN Overcoat by Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics — Product Code HSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2026
Date Received
March 11, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3520
Review Panel
OR
Submission Type

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