# Orthopedic Augmented Reality
> **Product code: SBF** · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.4560
## Classification
- **FDA Product Code:** SBF
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 882.4560
- **Review panel:** OR
- **Medical specialty:** Neurology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

An orthopedic augmented reality device provides visual guidance during orthopedic procedures, where the use of stereotaxic navigation is utilized. Visual guidance is displayed as “augmented reality” stereoscopic images to intraoperatively augment the user’s field of view.

## Market data
- **Cleared 510(k) submissions:** 42
- **Registered establishments:** 35
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=SBF)
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