Ankle Truss System (ATS)
FDA 510(k) clearance K230088 · decided 2024-03-21
Clearance details
- K-number
- K230088
- Device name
- Ankle Truss System (ATS)
- Applicant
- 4Web Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-01-12
- Decision date
- 2024-03-21
- Days to decision
- 434 days
- Clearance type
- Traditional
- Product code
- SAI
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Frisco, TX, 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 |
|---|---|---|
| TIDAL Fusion Cage System (K242356) | Restor3D, Inc. | 2025-03-24 |
Recalls involving this device
No recalls on record reference this clearance.