K252219
- 510(k) number
- K252219
- Device name
- Cervical Interbody and VBR Fusion System
- Applicant
- Sync Surgical TX · US
- Product code
- ODP — Intervertebral Fusion Device With Bone Graft, Cervic
- Decision date
- 2026-01-14
- Date received
- 2025-07-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K252219.pdf
Official FDA record: K252219
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.