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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Elbow, Hemi-, Radial, Polymer
510(k) Number K213563
Device Name DePuy Synthes Radial Head Replacement System
Applicant
Depuy Synthes
1301 Goshen Pkwy.
19380,  PA  19380
Applicant Contact Quinn McCarthy
Correspondent
Depuy Synthes
1301 Goshen Pkwy.
19380,  PA  19380
Correspondent Contact Quinn McCarthy
Regulation Number888.3170
Classification Product Code
KWI  
Date Received11/09/2021
Decision Date 03/18/2022
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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