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Spinal Channeling Instrument, Vertebroplasty

FDA product code OCJ · 1 cleared devices

Class 1 Orthopedic
Regulation
21 CFR 888.4540
Review panel
OR
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2007-07-10 – 2007-07-10

Create channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement (PMMA) prior to a vertebroplasty procedure. Treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions, and/or malignant lesions.

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