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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Cranioplasty, Preformed, Non-Alterable
510(k) Number K192702
Device Name DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional
Applicant
Synthes (USA) Products LLC
1301 Goshen Parkway
West Chester,  PA  19380
Applicant Contact Jeffrey Krawiec
Correspondent
Synthes (USA) Products LLC
1301 Goshen Parkway
West Chester,  PA  19380
Correspondent Contact Jeffrey Krawiec
Regulation Number882.5330
Classification Product Code
GXN  
Subsequent Product Codes
DZL   GWO   GXR   JEY   MQN  
Date Received09/27/2019
Decision Date 09/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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