FDA product code OAR

Injector, Vertebroplasty (Does Not Contain Cement)

Orthopedic·Class 1·21 CFR 888.4200
US regulatory classifications
US Product Code (FDA)
OAR
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 888.4200
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Medical specialty
Orthopedic
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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).

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About this record

Injector, Vertebroplasty (Does Not Contain Cement) is a medical device type in the Orthopedic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.