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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K180544
Device Name DePuy Synthes Static Staples
Applicant
Synthes (USA) Products, LLC
1301 Goshen Pkwy.
19380,  PA  19380
Applicant Contact Suchitra Basu
Correspondent
Synthes (USA) Products, LLC
1301 Goshen Pkwy.
19380,  PA  19380
Correspondent Contact Suchitra Basu
Regulation Number888.3030
Classification Product Code
JDR  
Date Received03/01/2018
Decision Date 07/24/2018
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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