SIT
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.1150
- Medical specialty
- Orthopedic
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| SportSuite Vision Software (DEN250040) | Stryker Endoscopy | 2026-07-17 |
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