FDA product code SIT: Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System
SIT is the FDA product code for arthroscopic or orthopedic endoscopic intraoperative augmented reality video see-through display system. It is a Class II device, regulated under 21 CFR 888.1150 and reviewed by the Orthopedic panel. Devices under SIT reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
This device consists of augmented reality software on a head-mounted display that displays arthroscopic or endoscopic video and medical imaging during orthopedic surgery. The device is intended to intraoperatively augment visualization with contextually relevant information and data, including that received from other devices.
Classification
| Field | Value |
|---|---|
| Device name | Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System |
| Device class | Class II |
| Regulation | 21 CFR 888.1150 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
Recalls for SIT devices
openFDA lists no recalls for product code SIT.
Frequently asked questions
What is FDA product code SIT?
SIT is the FDA product code for arthroscopic or orthopedic endoscopic intraoperative augmented reality video see-through display system. It is a Class II device, regulated under 21 CFR 888.1150 and reviewed by the Orthopedic panel.
What device class is SIT?
Class II, regulation 21 CFR 888.1150. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SIT
- Run a recall and safety report across every SIT manufacturer
- Watch product code SIT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.