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

Clearance record K231504

TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System · Vilex, LLC · decided 2023-09-11 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
TITANEX AZ-K190-11CVILEX LLCHXI00841731142870
TITANEX AC40-70T-16VILEX LLCHWC00841731141347
TITANEX AZ-100-TRYVILEX LLCFSM00841731147653
TITANEX AC40-26T-16CVILEX LLCHWC00841731140845
TITANEX AC40-28T-16VILEX LLCHWC00841731141132
TITANEX AC30-34T-11CVILEX LLCHWC00841731140081
TITANEX AC40-68T-16VILEX LLCHWC00841731141330
TITANEX AC30-46T-11CVILEX LLCHWC00841731140142
TITANEX TH20-22T-09VILEX LLCHWC00841731137579
TITANEX AC30-26T-11VILEX LLCHWC00841731140241
TITANEX AC30-42T-11CVILEX LLCHWC00841731140128
TITANEX TH20-36T-09VILEX LLCHWC00841731137647
TITANEX AC40-40T-16CVILEX LLCHWC00841731140913
TITANEX AC40-66T-16VILEX LLCHWC00841731141323
TITANEX TH20-34T-09VILEX LLCHWC00841731137630
TITANEX AC40-20T-16CVILEX LLCHWC00841731140814
TITANEX TH25-42T-11VILEX LLCHWC00841731137852
TITANEX AC40-64T-16VILEX LLCHWC00841731141316
TITANEX AC30-22T-11VILEX LLCHWC00841731140227
TITANEX AC40-52T-16CVILEX LLCHWC00841731140975
TITANEX AC30-40T-11CVILEX LLCHWC00841731140111
TITANEX TH20-46T-09VILEX LLCHWC00841731137692
TITANEX AZ-P102-22VILEX LLCLXH00841731148957
TITANEX AC40-20T-16VILEX LLCHWC00841731141095
TITANEX TH-DRILL-20VILEX LLCHTW00841731137913