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SIBN Stock Up After First-In-Patient Use of FDA Breakthrough Device
It features a pelvis-specific design to improve initial fixation and reduce the risk of screw backout ... of these initial procedures using the iFuse TORQ TNT system marks a significant step ...
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SI-BONE, Inc. Announces First-In-Patient Procedures with FDA Breakthrough Device for Pelvic Fracture Fixation
TNT, which received 510(k) clearance in August 2024 and was awarded Breakthrough Device Designation by the FDA, is the first 3D-printed transiliac-transsacral screw ... our iFuse TORQ TNT system ...
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SI-BONE, Inc. Receives 510(k) Clearance and FDA Breakthrough Device Designation for Pelvic Fracture Fixation System
clearance of the iFuse TORQ TNT™ Implant System (TNT). The TNT implant system is designed to meet the specific anatomical and bone mineral density needs of the sacrum and ilium and will serve as ...
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SI-BONE, Inc. Receives FDA 510(k) Clearance for a Smaller Diameter iFuse Bedrock Granite Implant with an Expanded Indication and Application
This 510(k) clearance follows the initial clearance of the iFuse Bedrock Granite System in ... segments in the spine, with reported screw loosening rates ranging from 16-41%,” 1,2,3 said Brian ...
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SI-BONE, Inc. Announces FDA Clearance for Expanded Rod Compatibility with the iFuse Bedrock Granite® Implant System
New cleared indications include use with a wide variety of commercially available pedicle screw system rods ... SI-BONE, iFuse Implant System, iFuse TORQ, Bedrock, and iFuse Bedrock Granite ...
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SI-BONE, Inc. Receives 510(k) Clearance and FDA Breakthrough Device Designation for Pelvic Fracture Fixation System
Aug. 20, 2024 (GLOBE NEWSWIRE) -- SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to providing surgical solutions for sacropelvic disorders, announces FDA 510(k) ...