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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cranial Surgical Planning And Instrument Guides
510(k) Number K253308
Device Name Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models
Applicant
Materialise NV
Technologielaan 15
Leuven,  BE 3001
Applicant Contact Polliane Carvalho
Correspondent
Materialise NV
Technologielaan 15
Leuven,  BE 3001
Correspondent Contact Polliane Carvalho
Regulation Number882.4310
Classification Product Code
PPT  
Date Received09/29/2025
Decision Date 01/07/2026
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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