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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 K210205
Device Name DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System
Applicant
Synthes (USA) products, LLC
1301 Goshen Parkway
West Chester,  PA  19380
Applicant Contact Satapa Dhamankar
Correspondent
Synthes (USA) products, LLC
1301 Goshen Parkway
West Chester,  PA  19380
Correspondent Contact Satapa Dhamankar
Regulation Number888.3030
Classification Product Code
HRS  
Date Received01/26/2021
Decision Date 03/26/2021
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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