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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nail, Fixation, Bone
510(k) Number K201336
Device Name DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm
Applicant
Synthes (USA) Products, LLC
1301 Goshen Pkwy.
19380,  PA  19380
Applicant Contact Pol Fort Grebol
Correspondent
Synthes (USA) Products, LLC
1301 Goshen Pkwy.
19380,  PA  19380
Correspondent Contact Pol Fort Grebol
Regulation Number888.3030
Classification Product Code
JDS  
Subsequent Product Code
HWC  
Date Received05/20/2020
Decision Date 09/03/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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