TIDAL Fusion Cage System
FDA 510(k) clearance K242356 · decided 2025-03-24
Clearance details
- K-number
- K242356
- Device name
- TIDAL Fusion Cage System
- Applicant
- Restor3D, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-08-08
- Decision date
- 2025-03-24
- Days to decision
- 228 days
- Clearance type
- Traditional
- Product code
- SAI
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Durham, NC, 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 |
|---|---|---|
| Ankle Truss System (ATS) (K230088) | 4Web Medical, Inc. | 2024-03-21 |
Recalls involving this device
No recalls on record reference this clearance.