SAI · Ankle Fusion Cage
Orthopedic · 21 CFR 888.3020 · Class 2
Overview
| Product Code | SAI |
|---|---|
| Device Name | Ankle Fusion Cage |
| Regulation | 21 CFR 888.3020 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
Classification Rationale
Class II.
Cleared Devices (2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242356 | TIDAL Fusion Cage System | Restor3D, Inc. | Mar 24, 2025 | SESE |
| K230088 | Ankle Truss System (ATS) | 4Web Medical, Inc. | Mar 21, 2024 | SESE |
Top Applicants
- Restor3D, Inc. — 1 clearance
- 4Web Medical, Inc. — 1 clearance
