FDA product code NUD

Vertebroplasty Compound, Calcium Based

Orthopedic·Class 2·21 CFR 888.3027·Implantable
US regulatory classifications
US Product Code (FDA)
NUD
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 888.3027
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Medical specialty
Orthopedic
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
Definition

THIS DEVICE IS INDICATED FOR THE FIXATION OF PATHOLOGICAL FRACTURES OF THE VERTEBRAL BODY USING VERTEBROPLASTY OR KYPHOPLASTY PROCEDURES. THE DEVICE RESORBS (TIME FRAME MAY BE INDICATED) AND IS REPLACED WITH BONE DURING THE HEALING PROCESS.

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About this record

Vertebroplasty Compound, Calcium Based 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. This device type includes implantable products.

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.