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510(k) K252846

TaperSet™ Hip System by Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2025
Date Received
September 8, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

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