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Injector, Vertebroplasty (Does Not Contain Cement)

FDA product code OAR · 1 cleared devices

Class 1 Orthopedic
Regulation
21 CFR 888.4200
Review panel
OR
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2005-09-06 – 2005-09-06

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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