SIT — Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System Class II
FDA product code SIT covers "Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System", a Class II medical device regulated under 21 CFR 888.1150. Submissions are reviewed by the Orthopedic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SIT
- Device Class
- Class II
- Regulation Number
- 888.1150
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN250040 | stryker endoscopy | SportSuite Vision Software | July 17, 2026 |