FDA

JUPITER, FL, December 10, 2024 — Atlas Spine, Inc., a spinal implant company based in Jupiter Florida, announced today they have received 510(k) clearance from the FDA for the HiJAK Expandable Lateral Lumbar Interbody System. Atlas is answering the evolving market needs of lateral fusion procedures with the introduction of HiJAK LLIF. Leveraging their clinically proven expandable technology, HiJAK LLIF is the latest addition to Atlas’ growing expandable interbody […]

CARLSBAD, Calif.–(BUSINESS WIRE)–Carlsmed, Inc. (“Carlsmed” or the “Company”) a MedTech company pioneering AI-enabled personalized spine surgery, today announced FDA 510(k) clearance for the aprevo® Cervical ACDF Interbody System. This milestone underscores Carlsmed’s commitment to advancing patient-specific spine surgery solutions that enhance outcomes and surgical precision. The FDA previously granted Breakthrough Device designation for Carlsmed’s aprevo® technology for the treatment […]

Astura Medical proudly announces the FDA 510(k) clearance of its latest innovation, the EGPS System. This system represents a significant advancement in spinal surgery, specifically designed to enhance compatibility and precision when used with robotic platforms. The EGPS System is crafted to work seamlessly across a range of surgical techniques and configurations, providing spinal surgeons […]

BERLIN, GERMANY, October 17, 2024 /EINPresswire.com/ — Fiagon GmbH is proud to announce a series of significant achievements, including the recent FDA clearance of the expanded Spine Platform and commercial launch in the United States at NASS 2024. Receiving FDA clearance for an extended platform from its Spine Navigation System Fiagon set a crucial milestone […]

SOUTH WINDSOR, Conn., Oct. 14, 2024 /PRNewswire-PRWeb/ — Oxford Performance Materials, Inc. (OPM; https://oxfordpm.com/), an industry leader in advanced materials science and 3D printing solutions for the orthopedic industry, is pleased to announce that OPM customer Vy Spine (https://Vy Spine.com/), has received FDA clearance for the OsteoFab® Lumbar Cage, which follows Vy Spine’s previous FDA approval for the OsteoFab® Cervical Cage. This […]

BOUNTIFUL, Utah–(BUSINESS WIRE)–Vy Spine, a spine innovation leader using differentiated materials and designs, announced today that it has received U.S. Food and Drug Administration (FDA) clearance for its LumiVy OsteoVy PEKK Lumbar IBF. The device is indicated for intervertebral body fusion for use at either one level or two contiguous levels in the lumbar spine, […]

Scottsdale, AZ – October 7, 2024–Foundation Surgical, an early-stage spinal implant company, is excited to announce the US Food &Drug Administration (FDA) 510(k) clearance of its Interwedge® Standalone Lateral Interbody System. This latest product clearance, used in conjunction with the Foundation’s new LLIF180™ procedure, represents a significant innovation in lateral spinal surgery. LLIF180™ is the […]

SpineGuard (FR0011464452 – ALSGD), an innovative company that deploys its DSG® (Dynamic Surgical Guidance) local conductivity sensing technology to secure and streamline the placement of bone implants, announced today the authorization under 510K #241895 by the FDA (Food and Drug Administration) to commercialize in the United States its new PsiFGuard device designed to secure the Posterior sacroiliac […]

Alzenau, 09/12/2024 – SIGNUS Medizintechnik GmbH is proud to announce the successful FDA approval of TETRIS ® ST and TETRIS ® R ST PLIF cages. These cages, made from structured titanium (ST), combine cutting-edge technology and materials, further expanding the innovative SIGNUS spinal surgery portfolio. SIGNUS is dedicated to continuously developing products with passion and […]

Plano, TX, September 06, 2024 –(PR.com)– The Eminent Spine Scoliosis Deformity Pedicle System consists of rods, polyaxial screws with set caps, and cross connectors with locking screws. Additionally, the system consists of rod connectors and iliac bolts with their respective locking screws. Rods are 5.5mm in diameter and are available either straight or pre-contoured. Straight and […]

FREMONT, Calif., Aug. 29, 2024 /PRNewswire/ — THINK Surgical, Inc., an innovator in the field of orthopedic surgical robots, today announced that its TMINI® Miniature Robotic System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use with the GMK® Sphere and SpheriKA® Knee Systems from Medacta International under a Collaboration Agreement between the two companies. The GMK […]

ATLANTA, July 31, 2024 /PRNewswire/ — MiRus has received Breakthrough Device Designation from the FDA for the EUROPA®Posterior Cervical System, based on it’s proprietary rhenium alloys, for treatment of the cervical and upper thoracic spine.  The EUROPA® PCF system is built around a 2.9 mm MoRe rod which is much smaller than current commercial systems. The lower diameter rod […]

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the ARx SAI (Sacral Alar Iliac) Spinal Fixation System. The ARx SAI Spinal Fixation System represents […]

KING OF PRUSSIA, PA — July 23, 2024 – Camber Spine, a leading innovator in spine and medical technologies, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its SPIRA-A Integrated technology. Part of the SPIRA product platform, the SPIRA-A Integrated Fixation System is an anterior lumbar interbody fusion device […]

GIÈRES (GRENOBLE), France and NASHVILLE, Tenn., July 22, 2024 /PRNewswire/ — eCential Robotics is proud to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for an innovative Spine Navigation and Robotic-Assistance Device. This device provides a new, advanced solution for planning and instrumenting spinal fusion procedures. This spine robot was developed by eCential Robotics […]

AUDUBON, Pa., July 17, 2024 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE: GMED), a leading musculoskeletal solutions company, today announced it recently received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for ExcelsiusFlex™ with Total Knee Arthroplasty (TKA) application. This new robotic navigation platform joins the already best-in-class Excelsius™ ecosystem, designed to offer surgeons control, resection accuracy, and procedural […]

PLEASANTON, Calif., June 13, 2024 /PRNewswire/ — Providence Medical Technology, Inc., an innovator in solutions for spinal surgery, announces that the U.S. Food and Drug Administration (FDA) has cleared the use of the CORUS™ Navigation Access System for use with the CORUS Spinal System during spinal surgery. The CORUS Navigation Access System is specifically designed for use with Medtronic’s […]

Eminent Spine’s SI Screw System includes 3D Printed Titanium and Machined Titanium. The implants are offered as non-sterile. Plano, TX, June 11, 2024 –(PR.com)– Eminent Spine received 510(k) approval on the 3D Printed Titanium and Machined Titanium SI Screw System as of June 4, 2024. Eminent Spine will showcase the SI Screw System at the State […]

Spinal Simplicity announces FDA clearance for its Wolff’s Law Anterior Cervical Plate System, a groundbreaking advancement in cervical spine treatment offering features like Active Compression and Auto-Lock Technology to enhance patient outcomes and surgical efficiency. OVERLAND PARK, Kan., June 10, 2024 /PRNewswire-PRWeb/ — Spinal Simplicity, a leading innovator in spinal healthcare solutions, proudly announces the FDA clearance […]

RA’ANANA, Israel–(BUSINESS WIRE)–VUZE Medical, a privately-held company aiming to transform intra-operative guidance in spinal interventions currently aided only by X-ray, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its second-generation VUZE System. The system’s current focus is on minimally invasive thoracolumbar stabilizations; however, the underlying VUZE technology is not specific to […]

GENEVA, May 28, 2024 /PRNewswire/ — Spineart, a fast-growing company specialized in spine surgery, proudly announces the 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its SCARLET® AC-Ti secured anterior cervical cage. The SCARLET® AC-Ti builds on a decade of experience with the SCARLET® system. The SCARLET® AC-Ti addition introduces new features such as […]

Bordeaux, Boston, May 13, 2024 – 6:00 pm CEST: IMPLANET (Euronext Growth: ALIMP, FR0013470168, eligible for PEA-PME equity savings plans), a medical technology company specializing in vertebral implants for orthopedic surgery and the distribution of technological medical equipment, today announced the Food and Drug Administration (FDA) 510(k) clearance of its new hybrid fixation system Jazz Spinal […]

Strasbourg, France,May 9, 2024. SC MEDICA, leader in facet fixation solutions, today announced that it has obtainedregulatory clearance from the United States Food and Drug Administration (FDA) for its medical device FFX®, a facet fixation system for use in lumbar spinal fusion surgery. This achievement was supported by compelling clinical evidence comparing FFX® and pedicle […]

Misgav, Israel, 06 May 2024 – ZygoFix Ltd. a portfolio company of The Trendlines Group Ltd. (“Trendlines”) announced  that it received regulatory clearance from the United States Food and Drug Administration (FDA clearance) for its zLOCK Lumbar Facet Fixation System. This achievement was supported by compelling clinical evidence from the company’s ongoing European clinical study, marking a significant advancement […]

WARSAW, Ind., May 02, 2024 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today announced it has received the “Breakthrough Device” Designation from the Food and Drug Administration (“FDA”) for its new eLLi surgical device, an implant designed to address severe pathology associated with Early Onset […]

The UniSpace® Stand-Alone C Cage received FDA 510(k) clearance in April 2024. This intervertebral body fusion device is a Class II medical device designed to promote optimal bone formation and reduce subsidence. The UniSpace® Stand-Alone C Cage has several key features that distinguish it as an advanced solution in spinal fusion technology. Its biomimetic lattice […]

IRVING, Texas, April 16, 2024 /PRNewswire/ — Xstim, Inc., a pioneering developer and manufacturer of cutting-edge bone growth stimulation systems, is thrilled to announce its recent Premarket Application (PMA) approval from the U.S. Food and Drug Administration (FDA) for Xstim™ Spine Fusion Stimulator. Engineered with patient comfort and convenience in mind, the Xstim™ Spine Fusion Stimulator represents […]