510(k) K251302
- Device
- OptiMesh Multiplanar Expandable Interbody Fusion System
- Applicant
- Spineology, Inc.
- 510(k) number
- K251302
- Product code
- OQB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-15
- Date received
- 2025-04-28
- Regulation
- 888.3085
- Classification name
- Intervertebral Body Graft Containment Device
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Megan Polos
- Address
- 7800 3rd St. N. Suite 600 Saint Paul MN US 55128 55128
FDA Registration Numbers#
- 2135156
- 1450662
Source Documents#
Other 510(k) Records For Product Code OQB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230927 | OptiMesh Multiplanar Expandable Interbody Fusion System | Spineology, Inc. | 2023-11-01 |
| K231781 | OptiMesh Multiplanar Expandable Interbody Fusion System | Spineology, Inc. | 2023-10-18 |
| DEN200010 | Spineology Interbody Fusion System | Spineology, Inc. | 2020-09-18 |