# Instruments Designed For Press-Fit Osteochondral Implants
> **Product code: QBO** · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.4505
## Classification
- **FDA Product Code:** QBO
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 888.4505
- **Review panel:** OR
- **Medical specialty:** Orthopedic
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

The device is intended to manipulate bone and cartilage tissue or implant materials for the positioning, alignment, defect creation, or placement of press-fit osteochondral implants.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 14
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QBO)
---
*AI Analytics · CC0 1.0*