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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Arthroplasty Implantation System
510(k) Number K241470
Device Name CORE Shoulder System
Applicant
LinkBio Corp.
69 King St.
Dover,  NJ  07801
Applicant Contact Deniz Kortan
Correspondent
LinkBio Corp.
69 King St.
Dover,  NJ  07801
Correspondent Contact Deniz Kortan
Regulation Number888.3660
Classification Product Code
QHE  
Subsequent Product Codes
KWS   PHX  
Date Received05/24/2024
Decision Date 02/20/2025
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
Recalls CDRH Recalls
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