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.
Recent Cleared Devices (2 of 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
- 4Web Medical, Inc. — 1 clearance
- Restor3D, Inc. — 1 clearance
