# Cranial Surgical Planning And Instrument Guides
> **Product code: PPT** · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.4310
## Classification
- **FDA Product Code:** PPT
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 882.4310
- **Review panel:** NE
- **Medical specialty:** Neurology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

Software and hardware for surgical planning to create patient-specific anatomical models, surgical templates, and guides for use in the marking or cutting of cranial bone for neurosurgical procedures.

## Market data
- **Cleared 510(k) submissions:** 4
- **Registered establishments:** 9
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PPT)
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