IN-DATE
G21-900027-SD: G21 Winch Kyphoplasty Balloon Catheter 11G x 15mm
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| Price: | $99.99 per box of 1 |
|---|---|
| Quantity: | |
| In Stock: | 2 box of 1 |
| Expiration: | 10-2026 |
AccessGUDID Info
- FDA Product Code: HRX
- FDA Product Code Name: Arthroscope
- FDA Product Code: NDN
- FDA Product Code Name: Cement, Bone, Vertebroplasty
- GMDN Term Code: 47021
- GMDN Term Name: Inflatable bone tamp
- GMDN Term Description: A catheter-like device with an inflatable balloon at the distal end used for the reduction of fractures and/or creation of a void in cancellous bone [e.g., in the spine for a vertebral compression fracture (VCF), hand, tibia, radius, and calcaneus]. It is commonly used for kyphoplasty, which involves its insertion into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated. After the device is removed, orthopaedic bone cement is introduced into the created void to stabilize the vertebra. This is a single-use device.
Manufacturer
G21 is an Italian medical device manufacturer specializing in acrylic-based bone cements and biomaterial solutions for orthopedic, spine, and oncology applications. Founded in 2009 and based in northern Italy’s medical device region, G21 develops PMMA bone cement systems used in arthroplasty, revision surgery, vertebroplasty, kyphoplasty, and related orthopedic procedures. The company’s portfolio includes standard and antibiotic-loaded bone cements, spinal cement systems, cement spacers, and related mixing/delivery solutions. G21 states that it maintains ISO 13485 certification and exports products to more than 35 countries.
