510(k) K150666 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
uNion Cervical Plate System
| Applicant | Ulrich Medical USA, Chesterfield MD, US |
| Decision | Substantially Equivalent, Jun 22, 2015 |
| Received | Mar 16, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150666
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.