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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K201944
Device Name DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
Applicant
Synthes (USA) Products, LLC
1301 Goshen Pkwy.
19380,  PA  19380
Applicant Contact Prem Pisupati
Correspondent
Synthes (USA) Products, LLC
1301 Goshen Pkwy.
19380,  PA  19380
Correspondent Contact Prem Pisupati
Regulation Number872.4760
Classification Product Code
JEY  
Date Received07/13/2020
Decision Date 09/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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