K250072
- 510(k) number
- K250072
- Device name
- CONDUIT SYNFIX Evolution Secured Spacer System
- Applicant
- Avalign Technologies, Inc. IN · US
- Product code
- OVD — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2025-07-10
- Date received
- 2025-01-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K250072.pdf
Official FDA record: K250072
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.