# Injector, Vertebroplasty (Does Not Contain Cement)
> **Product code: OAR** · Class I — Low Risk (general controls) · Orthopedic · 21 CFR 888.4200
## Classification
- **FDA Product Code:** OAR
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 888.4200
- **Review panel:** OR
- **Medical specialty:** Orthopedic
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

Intended for injection of vertebroplasty bone cement for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 69
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OAR)
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