K242516
- 510(k) number
- K242516
- Device name
- EUROPA Posterior Cervical Fusion System
- Applicant
- MiRus, LLC GA · US
- Product code
- NKG — Posterior Cervical Screw System
- Decision date
- 2024-11-19
- Date received
- 2024-08-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K242516.pdf
Official FDA record: K242516
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.