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

Intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy.

## Market data
- **Cleared 510(k) submissions:** 3
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OSF)
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