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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 K240567
Device Name CustomizedBone Service
Applicant
Fin-Ceramica Faenza S.P.A.
Via Ravegnana 186
Faenza,  IT 48018
Applicant Contact Marina Monticelli
Correspondent
Fortrea
5353 Wayzata Blvd. Suite 505
Minneapolis,  MN  55416
Correspondent Contact Stephanie Perryman
Regulation Number882.5330
Classification Product Code
GXN  
Subsequent Product Code
PJN  
Date Received02/29/2024
Decision Date 03/28/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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