Ulrich Medical USA Inc
FDA Regulatory Profile
Ulrich Medical USA Inc appears in FDA public data with 3 recalls, 12 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1350-2020, Class II) was initiated on December 31, 2019. Its most recent 510(k) clearance was granted on February 3, 2026.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 12
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1350-2020 | Class II | Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to | December 31, 2019 |
| Z-1126-2019 | Class II | ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set | March 8, 2019 |
| Z-1878-2017 | Class II | uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anter | March 7, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252087 | Navigation Module of the Cortium® System | February 3, 2026 |
| K251719 | Momentum® Posterior Spinal Fixation System | July 1, 2025 |
| K241396 | uCerv Flux-C 3D Porous Titanium Cervical Interbody | May 23, 2024 |
| K240515 | uNion® MAX Cervical Plate System | March 18, 2024 |
| K231809 | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Sp | October 20, 2023 |
| K230614 | Cortium | May 2, 2023 |
| K223274 | Momentum® MIS Posterior Spinal Fixation System | November 28, 2022 |
| K220696 | uCerv Flux-C 3D Porous Titanium Cervical Interbody | August 19, 2022 |
| K200845 | Navigation Module of the Momentum System | September 10, 2020 |
| K191932 | Momentum Posterior Spinal Fixation System | October 2, 2019 |
| K181921 | Solidity Vertebral Body Replacement | November 16, 2018 |
| K150666 | uNion Cervical Plate System | June 22, 2015 |