K243659
- 510(k) number
- K243659
- Device name
- FLASH Facet Fusion Instruments, IsoTis® Facet Fusion Instruments
- Applicant
- SeaSpine Orthopedics Corporation CA · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-04-02
- Date received
- 2024-11-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K243659.pdf
Official FDA record: K243659
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.