K240515
- 510(k) number
- K240515
- Device name
- uNion® MAX Cervical Plate System
- Applicant
- Ulrich Medical USA, Inc. TX · US
- Product code
- KWQ — Appliance, Fixation, Spinal Intervertebral Body
- Decision date
- 2024-03-18
- Date received
- 2024-02-23
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K240515.pdf
Official FDA record: K240515
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.