Data / Medical devices / United States / Ulrich Medical Usa, Inc.
Ulrich Medical Usa, Inc.: FDA-registered device maker in Plano, TX, United States, 12 510(k) clearances
Ulrich Medical Usa, Inc. is registered with the FDA (registration 3005823819) in Plano, TX, United States. It lists 13 device types. The FDA files 12 510(k) clearances under its listings, the newest dated February 3, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005823819
- FEI number
- 3005532635
- Address
- 3700 East Plano Parkway, Suite 200, Plano, TX, United States, 75074
- Owner or operator
- ULRICH MEDICAL USA, INC. (9062154)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 12, 2015
- Registered through
- 2026
- Brand names listed
- Angled Pusher, Control Handle, Cortium Universal OCT Spinal Fixation System, Momentum Deformity, Momentum MIS, Momentum Posterior Spinal Fixation System, Solidity Vertebral Body Replacement, V-Steady Cement and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 3, 2026 | K252087 | Navigation Module of the Cortium® System | OLO | Substantially Equivalent | Ulrich Medical USA, Inc. | accessdata.fda.gov |
| July 1, 2025 | K251719 | Momentum® Posterior Spinal Fixation System | NKB | Substantially Equivalent | Ulrich Medical USA, Inc. | accessdata.fda.gov |
| May 23, 2024 | K241396 | uCerv Flux-C 3D Porous Titanium Cervical Interbody | ODP | Substantially Equivalent | Ulrich Medical USA, Inc. | accessdata.fda.gov |
| March 18, 2024 | K240515 | uNion® MAX Cervical Plate System | KWQ | Substantially Equivalent | Ulrich Medical USA, Inc. | accessdata.fda.gov |
| October 20, 2023 | K231809 | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement | PML | Substantially Equivalent | Ulrich Medical USA | accessdata.fda.gov |
| May 2, 2023 | K230614 | Cortium | NKG | Substantially Equivalent | Ulrich Medical USA | accessdata.fda.gov |
| November 28, 2022 | K223274 | Momentum® MIS Posterior Spinal Fixation System | NKB | Substantially Equivalent | Ulrich Medical USA | accessdata.fda.gov |
| August 19, 2022 | K220696 | uCerv Flux-C 3D Porous Titanium Cervical Interbody | ODP | Substantially Equivalent | Ulrich Medical USA | accessdata.fda.gov |
| September 10, 2020 | K200845 | Navigation Module of the Momentum System | OLO | Substantially Equivalent | Ulrich Medical USA | accessdata.fda.gov |
| October 2, 2019 | K191932 | Momentum Posterior Spinal Fixation System | NKB | Substantially Equivalent | Ulrich Medical USA | accessdata.fda.gov |
| November 16, 2018 | K181921 | Solidity Vertebral Body Replacement | MQP | Substantially Equivalent | Ulrich Medical USA | accessdata.fda.gov |
| June 22, 2015 | K150666 | uNion Cervical Plate System | KWQ | Substantially Equivalent | Ulrich Medical USA | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 31, 2019 | 84638 | Class II | Terminated | Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw | Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" cannot reliably transmit the required torque of 3.5 Nm during installation. | accessdata.fda.gov |
| March 8, 2019 | 82497 | Class II | Terminated | ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct. | Certain Torque Limiting Handles in the field are beyond their 3 year calibration life. | accessdata.fda.gov |
| March 7, 2017 | 76740 | Class II | Terminated | uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical sp | Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating. | accessdata.fda.gov |
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Updated February 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.