K230927
- 510(k) number
- K230927
- Device name
- OptiMesh Multiplanar Expandable Interbody Fusion System
- Applicant
- Spineology, Inc. MN · US
- Product code
- OQB — Intervertebral Body Graft Containment Device
- Decision date
- 2023-11-01
- Date received
- 2023-04-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K230927.pdf
Official FDA record: K230927
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.