Device Approvals & Patents
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Spine/Neurology | Trauma/Sports
FDA OKs CarboFix's Carbon Fiber Vertebral Body Replacement System
The product to be officially launched during the Congress of Neurological Surgeons (CNS) in San Francisco, October 21-23, 2019.PR Newswire 10.17.19
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Spine/Neurology
FDA Clears Omnia Medical's PEEK-Optima HA Cervical Vertebral Body Replacement
Product offers the potential to improve bone apposition and patient outcomes.Omnia Medical LLC 10.17.19
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Spine/Neurology
FDA Grants 510(k) Clearance to 4WEB Medical's Cervical Stand-Alone Interbody Fusion Device
Company expands implant portfolio with the addition of the Cervical Spine Truss System - Stand-Alone.PR Newswire 10.15.19
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3-D Printing/Additive Mfg. | Instruments
FDA OKs OssDsign's Cranial PSI Accessories
The 3D-printed, patient-specific accessory devices support the company's FDA cleared cranioplasty implant.PR Newswire 10.14.19
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PAVmed is Granted a U.S. Patent Covering its CarpX Device
CarpX is designed to closely mimic the anatomic results of invasive carpal tunnel surgery, but much less invasively.Globe Newswire 10.14.19
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Large Joint | MIS/Robotics
FDA OKs THINK Surgical's Active Robot for Total Knee Replacement
Approval follows multi-center investigational clinical trial evaluating the safety and efficacy of TSolution One Total Knee Application.PR Newswire 10.10.19
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Spine/Neurology
FDA OKs Life Spine's Hinged Laminoplasty System
The laminoplasty procedure is an alternative to a laminectomy.Business Wire 09.26.19
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Spine/Neurology
Straightening Out a Spinal Device’s De Novo Pathway
Intellirod Spine and MCRA collaborated with FDA to take the first spinal device through the de novo pathway.Online Exclusives Sean Fenske, Editor-in-Chief 09.16.19
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Erchonia Receives FDA Clearance for Product to Relieve Chronic Musculoskeletal Pain
Clearance comes after the company submitted results from double-blind and placebo-controlled clinical trials with 255 patients.PR Newswire 09.16.19
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Extremities
FDA OKs Arthrosurface's BOSS Toe Fixation System
New joint preserving implant compatible with the Toe HemiCAP DF and ToeMotion Systems.PR Newswire 09.06.19
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Spine/Neurology
FDA OKs 4WEB's Cervical Stand-Alone Interbody Fusion Device
Company expands implant portfolio with the addition of the Cervical Spine Truss System - Stand-Alone.PR Newswire 08.29.19
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Coatings/Surface Modification | Spine/Neurology
FDA OKs First Spinal Device Using Promimic's HAnano Surface
“This represents a major breakthrough on the U.S. orthopedic market for us,” said Magnus Larsson, CEO at Promimic.Promimic 08.28.19
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Instruments | Spine/Neurology
FDA Clears Neurostimulation with SurGenTec's ALARA Access Needle Kit
The ALARA system is used for targeting and assisting in cannulating a pedicle.Business Wire 08.22.19
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Extremities
FDA Clears First Pediatric-Specific Foot System
OrthoPediatrics' PediFoot Deformity Correction System treats fractures and deformities of the foot and ankle.GlobeNewswire 08.19.19
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Spine/Neurology
FDA OKs First Device to Treat Pediatric Progressive Idiopathic Scoliosis
As a patient grows, Zimmer Biomet Spine's The Tether – Vertebral Body Tethering System corrects curvature while maintaining a fuller range of motion.U.S. Food and Drug Administration 08.16.19
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Spine/Neurology
MEDICREA Secures Several New Patents to Protect its UNiD ASI Technology
The new patents are directed to fundamental technologies and methods embedded in the UNiD ASI platform.Business Wire 08.09.19
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3-D Printing/Additive Mfg. | Spine/Neurology
Nexxt Spine Adds Stand Alone Cervical to NEXXT MATRIXX Family
Anticipated line extension of leading spinal device company available for pre-order.Business Wire 08.06.19
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Spine/Neurology
FDA OKs Medicrea's TULIP GENESIS, Completing Its UNiD ASI Platform Technology
TULIP GENESIS is a top-loading screw system.Business Wire 08.02.19
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Spine/Neurology
FDA OKs Life Spine's 8-10mm Width PROLIFT Expandable Spacers
The new sizes will more than double the company's current footprint options for the PROLIFT system.Business Wire 07.25.19
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Trauma/Sports
FDA OKs OrthoPediatrics' Next-Gen Cannulated Screw System
This enhanced system offers an “all-in-one” kit option and is optimized to increase operating room efficiency.GlobeNewswire 07.24.19
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