ulrich medical USA Inc
Plano, TX, US
ULRICH MEDICAL USA, INC. appears in FDA device records in Plano, TX. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for ulrich medical USA Inc between 2015 and 2026. The busiest year on record is 2022, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252087 | Navigation Module of the Cortium® System | OLO | Substantially Equivalent | |
| K251719 | Momentum® Posterior Spinal Fixation System | NKB | Substantially Equivalent | |
| K241396 | uCerv Flux™-C 3D Porous Titanium Cervical Interbody | ODP | Substantially Equivalent | |
| K240515 | uNion® MAX Cervical Plate System | KWQ | Substantially Equivalent | |
| 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 | |
| K230614 | Cortium™ | NKG | Substantially Equivalent | |
| K223274 | Momentum® MIS Posterior Spinal Fixation System | NKB | Substantially Equivalent | |
| K220696 | uCerv Flux-C 3D Porous Titanium Cervical Interbody | ODP | Substantially Equivalent | |
| K200845 | Navigation Module of the Momentum System | OLO | Substantially Equivalent | |
| K191932 | Momentum™ Posterior Spinal Fixation System | NKB | Substantially Equivalent | |
| K181921 | Solidity Vertebral Body Replacement | MQP | Substantially Equivalent | |
| K150666 | uNion Cervical Plate System | KWQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005823819 | 3005532635 | ULRICH MEDICAL USA, INC. | 3700 East Plano Parkway, Suite 200, Plano, TX 75074 US | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- PMLBone Cement, Posterior Screw Augmentation
- KTZCaliper
- HWAImpactor
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- NKGPosterior Cervical Screw System
- HXXScrewdriver
- MQPSpinal Vertebral Body Replacement Device
- HWXTap, Bone
- NKBThoracolumbosacral Pedicle Screw System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1350-2020 | 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. | Class II | Terminated | |
| Z-1126-2019 | 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. | Class II | Terminated | |
| Z-1878-2017 | 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 spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion. | Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain