K252327
- 510(k) number
- K252327
- Device name
- CMORE® CT System; CMORE® CT System Navigated Instruments
- Applicant
- Icotec AG CH
- Product code
- NKG — Posterior Cervical Screw System
- Decision date
- 2025-11-12
- Date received
- 2025-07-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K252327.pdf
Official FDA record: K252327
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.