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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, fixation, bone
510(k) Number K201578
Device Name DePuy Synthes Variable Angle Locking Patella Plating System
Applicant
Synthes (USA) Products, LLC
1301 Goshen Parkway
west chester,  PA  19380
Applicant Contact enrico gindro
Correspondent
Synthes (USA) Products, LLC
1301 Goshen Parkway
west chester,  PA  19380
Correspondent Contact enrico gindro
Regulation Number888.3030
Classification Product Code
HRS  
Date Received06/11/2020
Decision Date 09/09/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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