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ulrich medical USA Inc

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
12
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1350-2020Class IIUlrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-toDecember 31, 2019
Z-1126-2019Class IIULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of setMarch 8, 2019
Z-1878-2017Class IIuNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterMarch 7, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K252087Navigation Module of the Cortium® SystemFebruary 3, 2026
K251719Momentum® Posterior Spinal Fixation SystemJuly 1, 2025
K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyMay 23, 2024
K240515uNion® MAX Cervical Plate SystemMarch 18, 2024
K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior SpOctober 20, 2023
K230614Cortium™May 2, 2023
K223274Momentum® MIS Posterior Spinal Fixation SystemNovember 28, 2022
K220696uCerv Flux-C 3D Porous Titanium Cervical InterbodyAugust 19, 2022
K200845Navigation Module of the Momentum SystemSeptember 10, 2020
K191932Momentum™ Posterior Spinal Fixation SystemOctober 2, 2019
K181921Solidity Vertebral Body ReplacementNovember 16, 2018
K150666uNion Cervical Plate SystemJune 22, 2015