OAR

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Injector, Vertebroplasty (Does Not Contain Cement)

Device class

Class I (low risk)

Regulation

21 CFR 888.4200

Medical specialty

Orthopedic

FDA 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).

Adverse events (MAUDE)

2016: 9 · 2017: 22 · 2019: 14 · 2021: 13 · 2024: 17 · 2026: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.