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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K243637

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery · Materialise NV · decided 2025-02-21 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
TruMatchSD980.017Materialise NVJEY05420060380174
TRUMATCHSD980.028Materialise NVDZJ LLZ05420060380747
TRUMATCHSD980.038Materialise NVDZJ LLZ05420060380884
TRUMATCHSD980.035Materialise NVDZJ LLZ05420060380853
TRUMATCHSD980.036Materialise NVDZJ LLZ05420060380860
TRUMATCHSD980.037Materialise NVDZJ LLZ05420060380877
TRUMATCHSD980.032Materialise NVDZJ LLZ05420060380761
TRUMATCHSD980.034Materialise NVDZJ LLZ05420060380846
TruMatchSD980.104Materialise NVJEY05420060381041
TruMatchSD980.015Materialise NVJEY05420060380150
TRUMATCHSD980.033Materialise NVDZJ LLZ05420060380839
TRUMATCHSD980.039Materialise NVDZJ LLZ05420060380891
TRUMATCHSD980.040Materialise NVDZJ LLZ05420060380907
TRUMATCHSD980.031Materialise NVDZJ LLZ05420060380754