DeviceClearance

Product code OAR— Orthopedic

PARALLAX EZFLOW CEMENT DELIVERY SYSTEM

Classification name
Injector, Vertebroplasty (Does Not Contain Cement)
Device class
Class 1
Regulation
21 CFR 888.4200
Advisory panel
Orthopedic
Total cleared
1
First cleared
Most recent

FDA classification 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).”

— U.S. Food and Drug Administration, device classification record for product code OAR under 21 CFR 888.4200, via openFDA

Market context for product code OAR

FDA has cleared 1 device under product code OAR, all in 2005, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code OAR

Recent clearances under product code OAR

Data sourced from openFDA. This site is unofficial and independent of the FDA.