# Orthopedic Stereotaxic Instrument
> **Product code: OLO** · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.4560
## Classification
- **FDA Product Code:** OLO
- **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

Stereotaxic guidance during orthopedic surgery procedures.  Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

## Market data
- **Cleared 510(k) submissions:** 423
- **Registered establishments:** 380
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OLO)
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