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, a class II device type, regulated under 21 CFR 888.1150. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SIT
- Device name
- Arthroscopic Or Orthopedic Endoscopic Intraoperative Augmented Reality Video See-Through Display System
- 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.
- Regulation
- 21 CFR 888.1150
- Device class
- Class II
- Review panel
- Orthopedic
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code SIT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2026 | 1 |
Applicants with the most clearances
Product code SIT| Applicant | Clearances |
|---|---|
| Stryker Corp. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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