K242356
- 510(k) number
- K242356
- Device name
- TIDAL Fusion Cage System
- Applicant
- Restor3D, Inc. NC · US
- Product code
- SAI — Ankle Fusion Cage
- Decision date
- 2025-03-24
- Date received
- 2024-08-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K242356.pdf
Official FDA record: K242356
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.