OptiMesh Multiplanar Expandable Interbody Fusion System— 510(k) K230927
Substantially EquivalentSpineology, Inc.
FDA 510(k) clearance K230927 for OptiMesh Multiplanar Expandable Interbody Fusion System, Substantially Equivalent on 2023-11-01. Applicant: Spineology, Inc.. Device class: 2.
Clearance details
- Applicant
- Spineology, Inc.
- Product code
- Code OQB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3085
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Saint Paul, MN, US
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