FDA 510(k) Clearance
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Regulatory
Meditech Spine Receives FDA Clearance for its CURE™ OPEL-L (S) system
ATLANTA, June 1, 2020 /PRNewswire/ — Meditech Spine has received FDA 510(k) clearance to market the CURE™ Opel-L (S) system, a new lumbar…
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Regulatory
FDA Grants Clearance on Nexxt Spine ALIF and Lateral Systems
Additional FDA clearances roll in for growing spinal manufacturer to be available Q3 May 28, 2020- Noblesville, IN– Nexxt Spine…
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Extremities
Nextremity Solutions, Inc. Receives FDA 510(k) Clearance for Metatarsophalangeal Joint (MPJ) Arthrodesis System
WARSAW, IND. (PRWEB) MAY 21, 2020 Nextremity Solutions, Inc., a strategic commercialization organization with a focus on the extremity musculoskeletal space,…
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Regulatory
Zebra Medical Vision Secures its 5th FDA Clearance, Making Its Vertebral Compression Fractures AI Solution Available in the U.S.
May 18, 2020 KIBBUTZ SHEFAYIM, Israel–(BUSINESS WIRE)–Zebra Medical Vision, the deep-learning medical imaging analytics company, announces today its fifth FDA…
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Regulatory
HD LifeSciences Receives 510(k) Clearance for Hive™ ALIF Standalone System
BOSTON, MA, May 12th, 2020 – HD LifeSciences has received 510(k) clearance from the U.S Food and Drug Administration (FDA)…
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Spine
NuVasive Expands Advanced Materials Science™ Implant Portfolio to Additional Thoracolumbar Procedures
SAN DIEGO, May 5, 2020 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with…
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Regulatory
Astura Medical Receives FDA 510(k) Clearance For El Capitan Lumbar Interbody Fusion System
IRVING, TX – April 30, 2020 – Astura Medical, a high-growth, innovative spine technology company, today announced that it has…
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Regulatory
Life Spine Announces FDA 510(k) Clearance for Implant and Instrument Additions to the ARx® Spinal System for Adult Deformity
April 28, 2020 HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the…
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Spine
Life Spine Announces FDA 510(k) Clearance of the PROLIFT® Lateral Fixated System
April 21, 2020 HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the…
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Regulatory
Astura Medical Receives FDA 510(k) Clearance For SIRION Lateral Lumbar Interbody Fusion System
IRVING, TX – April 14, 2020 – Astura Medical, a high-growth, innovative spine technology company, today announced that it has…
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Regulatory
TDi™| SonoVision™ Receives 510(k) Clearance for the First Machine Learning Enabled Ultrasound Product in Spine Surgery
DELRAY BEACH, Fla., April 14, 2020 /PRNewswire/ — Tissue Differentiation Intelligence, LLC (TDi™), a company specializing in real-time surgical ultrasound imaging, today…
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