# Orthopaedic Surgical Planning And Instrument Guides
> **Product code: PBF** · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3030
## Classification
- **FDA Product Code:** PBF
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 888.3030
- **Review panel:** OR
- **Medical specialty:** Orthopedic
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

As a surgical instrument to assist in pre-operative planning and/or guiding the marking of bone and/or guide surgical instruments for orthopedic surgical procedures.

## Market data
- **Cleared 510(k) submissions:** 27
- **Registered establishments:** 34
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PBF)
---
*AI Analytics · CC0 1.0*