Company · US
Ulrich Medical USA
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2026. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (1 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 3 |
| NKB | Thoracolumbosacral Pedicle Screw System | 3 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 |
| OLO | Orthopedic Stereotaxic Instrument | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 |
| LXL | 1 | |
| MQP | Spinal Vertebral Body Replacement Device | 1 |
| NKG | Posterior Cervical Screw System | 1 |
| PML | Bone Cement, Posterior Screw Augmentation | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 3, 2026 | K252087 | Navigation Module of the Cortium® System Ulrich Medical USA, Inc. | OLO |
| Jul 1, 2025 | K251719 | Momentum® Posterior Spinal Fixation System Ulrich Medical USA, Inc. | NKB |
| May 23, 2024 | K241396 | uCerv Flux-C 3D Porous Titanium Cervical Interbody Ulrich Medical USA, Inc. | ODP |
| Mar 18, 2024 | K240515 | uNion® MAX Cervical Plate System Ulrich Medical USA, Inc. | KWQ |
| Oct 20, 2023 | K231809 | Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System Ulrich Medical USA | PML |
| May 2, 2023 | K230614 | Cortium Ulrich Medical USA | NKG |
| Nov 28, 2022 | K223274 | Momentum® MIS Posterior Spinal Fixation System Ulrich Medical USA | NKB |
| Aug 19, 2022 | K220696 | uCerv Flux-C 3D Porous Titanium Cervical Interbody Ulrich Medical USA | ODP |
| Sep 10, 2020 | K200845 | Navigation Module of the Momentum System Ulrich Medical USA | OLO |
| Oct 2, 2019 | K191932 | Momentum Posterior Spinal Fixation System Ulrich Medical USA | NKB |
| Nov 16, 2018 | K181921 | Solidity Vertebral Body Replacement Ulrich Medical USA | MQP |
| Jun 22, 2015 | K150666 | uNion Cervical Plate System Ulrich Medical USA | KWQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 31, 2019 | ulrich medical USA Inc Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw Terminated |
KWP | K150650 |
| Mar 8, 2019 | ulrich medical USA Inc ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct. Terminated |
LXL | K102853 K123717 +1 |
| Apr 26, 2017 | Ulrich Medical USA Inc 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 Terminated |
KWQ | K150666 |