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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 K191463
Device Name DePuy Synthes Hammertoe Continuous Compression Implant
Applicant
Synthes (USA) Products, LLC
1301 Goshen Pkwy.
West Chester,  PA  19380
Applicant Contact Keith Knapp
Correspondent
Synthes (USA) Products, LLC
1301 Goshen Pkwy.
West Chester,  PA  19380
Correspondent Contact Keith Knapp
Regulation Number888.3030
Classification Product Code
JDR  
Date Received06/03/2019
Decision Date 02/26/2020
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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