K231781
- 510(k) number
- K231781
- Device name
- OptiMesh Multiplanar Expandable Interbody Fusion System
- Applicant
- Spineology, Inc. MN · US
- Product code
- OQB — Intervertebral Body Graft Containment Device
- Decision date
- 2023-10-18
- Date received
- 2023-06-16
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K231781.pdf
Official FDA record: K231781
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.