uNion Cervical Plate System— 510(k) K150666

Clearance details

Applicant

Ulrich Medical USA

Product code

Code KWQ

Device class

Class 2

Regulation

21 CFR 888.3060

Advisory panel

Orthopedic

Date received

2015-03-16

Decision date

2015-06-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Chesterfield, MD, US

• K261309 — Palisades Buttress Plate System2026-07-16
• K252776 — ARIES Anterior Cervical Plate Systems2026-05-14
• K261112 — CastleLoc-P Anterior Cervical Plate System2026-05-06
• K260570 — corra cervical plating system2026-04-22
• K260697 — VyPlate Anterior Cervical Plate System2026-03-27

• K231809 — Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement +1 more2023-10-20
• K230614 — Cortium2023-05-02
• K223274 — Momentum® MIS Posterior Spinal Fixation System2022-11-28
• K220696 — uCerv Flux-C 3D Porous Titanium Cervical Interbody2022-08-19
• K200845 — Navigation Module of the Momentum System2020-09-10

Death

8

Injury

1,212

Malfunction

1,233

Total

2,453

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• 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.Class II·Terminated·Ulrich Medical USA Inc·20170307

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150666.