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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

Orthopedics and Spine

OSSIO Receives FDA 510(k) Clearance for OSSIOfiber Hammertoe Fixation System 

OSSIO, Inc., an orthopedic fixation company, today announced that its OSSIOfiber® Hammertoe Fixation System has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis and bone...

March 12, 2020

Orthopedics and Spine

TriMed, Inc. Announces Release of the ASET™ Foot Plating Systems 

TriMed, Inc. an orthopaedic medical device developer and manufacturer focused on extremities, announced it would begin marketing its new ASET™ Foot Plating System. The ASET Foot Plating System, designed to treat common forefoot and mid-foot indications, offers unique implants to...

March 10, 2020

Orthopedics and Spine

CrossRoads Extremity Systems, LLC Announces Launch of the HiMax Plus Widebody Fixation System for Foot Fusions

CrossRoads® Extremity Systems, the global leader in Staple Compression Plates(SCP) and nitinol technology for the lower extremities, announced it has received FDA clearance and launched the HiMax® Plus Widebody Fixation System. HiMax® Plus is the only foot bone fusion system on the market to provide...

February 18, 2020

Orthopedics and Spine

MEDICREA Announces FDA Clearance of the World’s First Patient-Matched Spinal Interbody Cages

MEDICREA® (Euronext Growth Paris : FR0004178572 – ALMED, PEA-PME eligible and OTCQX : MRNTF), pioneering the transformation of spinal surgery through Artificial Intelligence, predictive modeling and patient specific implants with its UNiD® ASI (Adaptive Spine Intelligence) proprietary software platform, concierge expert services...

February 13, 2020