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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 K243715
Device Name Synthes Patient Specific Implants
Applicant
Synthes GmbH
Luzernstrasse 21
Zuchwil,  CH 4528
Applicant Contact Thomas Shea
Correspondent
Synthes GmbH
Luzernstrasse 21
Zuchwil,  CH 4528
Correspondent Contact Thomas Shea
Regulation Number882.5330
Classification Product Code
GXN  
Date Received12/02/2024
Decision Date 11/12/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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