fda clearance
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Spine
Landmark Clinical Study Demonstrates Superiority of 3-Level Circumferential Cervical Fusion Over Anterior Cervical Fusion Alone
FDA clears CORUS™ PCSS for multilevel circumferential cervical fusion procedures based on results from the prospective, multicenter, randomized, controlled FUSE…
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Spine
Providence Medical Technology, Inc. Announces FDA Clearance of CORUS™ Navigation Access System for Use with Medtronic’s StealthStation™ Surgical Navigation in Posterior Spinal Fusion
PLEASANTON, Calif., June 13, 2024 /PRNewswire/ — Providence Medical Technology, Inc., an innovator in solutions for spinal surgery, announces that the U.S. Food and…
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Regulatory
Spinal Simplicity Announces FDA Clearance of Its Wolff’s Law Anterior Cervical Plate System
Spinal Simplicity announces FDA clearance for its Wolff’s Law Anterior Cervical Plate System, a groundbreaking advancement in cervical spine treatment…
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Spine
ZygoFix Receives FDA Clearance for its zLOCK Lumbar Facet Fixation System
MISGAV, Israel, May 6, 2024 /PRNewswire/ — ZygoFix Ltd. a portfolio company of The Trendlines Group Ltd. (“Trendlines”) announced that it received regulatory clearance from the United…
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Spine
SAIL Fusion Announces FDA Clearance of its BowTie™ Sacroiliac Fusion System
BowTie is the Only SI Fusion Device to Incorporate Intra-Articular and Transfixing Components DEL MAR, Calif., April 23, 2024–(BUSINESS WIRE)–SAIL…
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Regulatory
BioRestorative Therapies Announces FDA Clearance of Phase 2 BRTX-100 Clinical Study Protocol Amendment
— Amendment replaces saline injections with sham injections in the control group — MELVILLE, N.Y., April 16, 2024 (GLOBE NEWSWIRE)…
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Regulatory
Peleton Surgical Receives First-Ever FDA Clearance to Market Innovative Single-Use Surgical Power Driver
Peleton’s surgical power innovation program enhances financial control, improves surgical flexibility, and reduces patient risk SCOTTSDALE, Ariz., April 10, 2024…
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Spine
Inspire® 3D Printed Trabecular PEEK™ With HAFUSE® Lumbar Interbody System Cleared by FDA
Huntsville, AL based technology manufacturer Curiteva announced FDA 510(k) clearance of the Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion…
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Spine
Providence Medical Technology Announces FDA Clearance of CAVUX® FFS-LX Lumbar Facet Fixation System for 1- and 2-Level Lumbar Spinal Fusion
CAVUX FFS-LX Achieved 96% Fusion Rate Verified by Independent Core Imaging Lab in Recent Clinical Study PLEASANTON, Calif., Jan. 11, 2024 /PRNewswire/…
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Spine
ulrich medical USA® Announces FDA Clearance for Expanded Indications of Momentum® and Momentum® MIS Systems
Momentum and Momentum MIS Posterior Spinal Fixation Systems and V-STEADY Bone Cement Expanded indications allow Posterior Spinal Fixation Systems to…
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Regulatory
ZimVie Announces Compatibility Between its Vital™ Spinal Fixation System and Brainlab Spine & Trauma Navigation
WESTMINSTER, Colo., Dec. 12, 2023 (GLOBE NEWSWIRE) — ZimVie Inc. (Nasdaq: ZIMV), a global life sciences leader in the dental…
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Regulatory
OSSIO’s Groundbreaking Option for Fixing Bone Fractures In Children Receives FDA Clearance
OSSIOfiber Intelligent Bone Regeneration Technology Supported by Clinical Data Presented at IPOS 2023, Pediatric Indication for OSSIOfiber® Bio-Integrative Orthopedic Fixation Technology…
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Spine
Vy Spine Announces FDA Clearance for its ClariVy OsteoVy PEKK Cervical IBF
Tallahassee, FL., November 14, 2023 – OrthoSpineNews – Vy Spine, a spine innovation leader using differentiated materials and designs, announced…
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Regulatory
VySpine Announces FDA Clearances for VySpan, VyLam and VySpine Innovations
Trio of Clearances Expands VySpine’s Growing Product Portfolio Tallahassee, FL – October 17, 2023—VySpine, a spine innovation leader using…
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Regulatory
FDA clears Intelivation Technologies new Hammerdesis™ Interphalangeal Fusion System
SAINT SIMONS ISLAND, Ga., Oct. 10, 2023 /PRNewswire/ — Intelivation Technologies, an innovative medical device company with a cutting-edge orthopedic portfolio announced…
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