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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
510(k) Number K230831
Device Name INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid
Applicant
Depuy Ireland UC
Loughbeg
Ringaskiddy,  IE
Applicant Contact Yayoi Fujimaki
Correspondent
Ignite Orthopedics, LLC
700 Park Ave.
Suite F
Winona Lake,  IN  46590
Correspondent Contact Russ Parrott
Regulation Number888.3670
Classification Product Code
MBF  
Subsequent Product Codes
HSD   KWS   KWT   PAO   PKC  
Date Received03/27/2023
Decision Date 11/13/2023
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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