OptiMesh Multiplanar Expandable Interbody Fusion System
FDA 510(k) clearance K251302 · decided 2025-12-15
Clearance details
- K-number
- K251302
- Device name
- OptiMesh Multiplanar Expandable Interbody Fusion System
- Applicant
- Spineology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-04-28
- Decision date
- 2025-12-15
- Days to decision
- 231 days
- Clearance type
- Traditional
- Product code
- OQB
- Device class
- 2
- Regulation number
- 888.3085
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Saint Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OptiMesh Multiplanar Expandable Interbody Fusion System (K230927) | Spineology, Inc. | 2023-11-01 |
| OptiMesh Multiplanar Expandable Interbody Fusion System (K231781) | Spineology, Inc. | 2023-10-18 |
| Spineology Interbody Fusion System (DEN200010) | Spineology, Inc. | 2020-09-18 |
Recalls involving this device
No recalls on record reference this clearance.