B-Two®
Kyphoplasty Balloon and Vertebral Access System

Features
• Radiopaque balloon landmarks
• Sharpened access system
• Needle graduation marking to adjust the penetration depth
• 3 sizes of balloon catheter (10, 15, 20 mm)
• Analogical pressure meter
• Unilateral access
Intended use
B-Two® (Inflatable Bone Expander System) Balloon Catheter is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine during balloon Kyphoplasty.
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DESIGNATION
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REFERENCE EXCEPT U.S.
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REFERENCE U.S. ONLY
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B-Two® size 10
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T101010
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US101010
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B-Two® size 15
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T101015
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US101015
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B-Two® size 20
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T101020
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US101020
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U.S. federal law restricts this device to sale by or on the order of a physician (or properly licensed practitioner) or on the physician’s prescription.