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Orthopedics and Spine
4WEB Medical Announces FDA 510(k) Clearance of Stand-Alone Anterior Lumbar Interbody Fusion Device
4WEB Medical, an orthopedic device company focused on developing innovative implants with an Advanced Structural Design that utilizes its proprietary Truss Implant Technology™, announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to...
June 10, 2020
Orthopedics and Spine
GTX medical Granted FDA Breakthrough Device Designation for Go-2 Targeted Epidural Spinal Stimulation (TESS) System
GTX medical (GTX), today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its implantable Go-2 system which was designed to promote the recovery of leg motor functions and neurological control in adults with...
June 9, 2020
Orthopedics and Spine
Centinel Spine Announces FDA Approval for the Manufacturing Transfer of prodisc Technology
Centinel Spine, LLC, the largest privately-held spine company focused on anterior column reconstruction, today announced FDA approval for the manufacturing transfer of both the prodisc® C Cervical Total Disc Replacement and prodisc® L Lumbar Total Disc Replacement systems to new strategic vendors. The FDA...
May 27, 2020
Orthopedics and Spine
Smith & Nephew launches new JOURNEY II Unicompartmental Knee System
Smith+Nephew, the global medical technology business, today announces the launch of its new JOURNEY II Unicompartmental Knee (UK) System. Built on the heritage of one of the most clinically successful partial knees,1,2 and paired with proprietary OXINIUM™ Technology, JOURNEY II UK is...
May 20, 2020
Orthopedics and Spine
Zebra Medical Vision Secures its 5th FDA Clearance, Making Its Vertebral Compression Fractures AI Solution Available in the U.S.
Zebra Medical Vision, the deep-learning medical imaging analytics company, announces today its fifth FDA 510(k) clearance for its Vertebral Compression Fractures (VCF) product. The company’s latest AI solution automatically identifies findings suggestive of compression fractures, enabling clinicians to place patients...
May 18, 2020
Orthopedics and Spine
FDA grants Carmell Therapeutics Expedited Review for CT-101, Bone Healing Accelerant 
Carmell Therapeutics, a pioneer in the development and commercialization of innovative Plasma-based Bioactive Materials (PBMs) to accelerate bone and soft tissue healing, announced that the U.S. Food and Drug Administration (FDA) last week has granted Fast Track designation for the...
April 27, 2020
Orthopedics and Spine
Centinel Spine Announces FDA Approval for Two-level prodisc L Total Disc Replacement
Centinel Spine®, LLC, the largest privately-held spine company focused on anterior column reconstruction, today announced FDA approval of two-level indications for the prodisc® L Lumbar Total Disc Replacement (TDR) system. Centinel Spine now becomes the only company in the world with an...
April 16, 2020
Orthopedics and Spine
Precision Spine Announces the Worldwide Launch of the Reform Ti Pedicle Screw System Providing Surgeons with Increased Flexibility, Versatility, and Visibility 
Precision Spine, Inc., a medical device company dedicated to Made-in-the-USA manufacturing, has launched world wide the Reform® Ti Titanium Pedicle Screw System, which provides surgeons with the increased flexibility, versatility, and visibility that is required during today’s challenging degenerative and trauma spine...
April 8, 2020
Orthopedics and Spine
Orthofix Completes Acquisition of FITBONE Limb Lengthening System 
Orthofix Medical Inc., a global medical device company focused on musculoskeletal healing products, today announced it has completed the acquisition of assets associated with the FITBONE® intramedullary lengthening system for limb lengthening of the femur and tibia bones. The transaction also...
March 26, 2020
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