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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
510(k) Number K243248
Device Name INHANCE INTACT™
Applicant
Depuy Ireland UC
Loughbeg Ringaskiddy
Ringaskiddy,  IE
Applicant Contact Sanjay Shah
Correspondent
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46582
Correspondent Contact Sanjay Shah
Regulation Number888.3660
Classification Product Code
PKC  
Subsequent Product Codes
KWS   KWT   MBF   PAO  
Date Received10/11/2024
Decision Date 12/23/2024
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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