375 results found.
                    
Life Spine Gains FDA Clearance for LONGBOW Titanium Spacer
Life Spine was granted FDA 510(k) clearance to market the LONGBOW® Titanium Lateral Expandable Spacer.
NuVasive Gains Additional FDA Clearance for CoRoent Small Interlock
NuVasive received FDA 510(k) clearance for expanded indications for the CoRoent Small Interlock™ system.
DiFusion Gains FDA Clearance for Xiphos ZFUZE Biomaterial
DiFusion received FDA 510(k) clearance for the Xiphos-ZF spinal interbody device made from ZFUZE biomaterial. Product launch will occur within 4Q19.
Stryker Gains FDA Clearance for SAHARA Lateral 3D Expandable Interbody
Stryker received FDA 510(k) clearance to market the SAHARA® Lateral 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology.
Nanovis Gains FDA Clearance for Bioceramic Nanotube Surface
Nanovis received the first FDA 510(k) clearance for a bioceramic nanotube surface that demonstrates FDA's requirements for nanotechnology.
CarboFix Gains FDA Clearance for Carbon Fiber VBR
CarboFix received FDA 510(k) clearance to market CarboClear® Carbon Fiber Vertebral Body Replacements.
Aegis Spine Gains FDA Clearance for AccelFix Expandable Cage
Aegis Spine received FDA 510(k) clearance to market the AccelFix Expandable Cage System.
Epica Gains FDA Clearance for SeeFactorCT3
Epica was granted FDA 510(k) clearance to market the SeeFactorCT3™ Imaging Platform, comprising computed tomography, fluoroscopy and digital radiography in one syst...
Back 2 Basics Gains FDA Clearance for Carbon Interbody Cages
Back 2 Basics received FDA 510(k) clearance to market eCarbon anterior cervical and posterior lumbar Interbody devices.
DeGen Medical Gains New FDA Clearances
DeGen Medical received FDA clearance to market the F1 MPS™ Modular Pedicle Screw System for JOUST™ Minimally Invasive Surgery and the Cyclops™ Anterior Cer...
SpineWelding Gains FDA Clearance for Elaris Pedicle Screw
SpineWelding received its first FDA 510(k) clearance, addressing the Elaris Pedicle Screw.
Life Spine Gains FDA Clearance for Hinged Laminoplasty System
Life Spine was granted FDA 510(k) clearance to market a Hinged Laminoplasty System.
Brainlab's Cirq Robotics Gains FDA Clearance for Spine
Brainlab received FDA 510(k) clearance to market Cirq® Robotics in the U.S. for spinal applications.
CarboFix Gains FDA Clearance for Carbon Fiber Fenestrated Screw
CarboFix received FDA 510(k) clearance to market CarboClear® Carbon Fiber fenestrated pedicle screws to treat spinal tumors. 
Omnia Medical Gains FDA Clearance for PEEK-OPTIMA HA Cervical VBR
Omnia Medical received FDA 510(k) clearance to market the Boxcar cervical vertebral body replacement.
Atlas Spine Gains FDA Clearance of V3 Guided Segmental Plating
Atlas Spine received FDA 510(k) clearance to market the V3 Guided Segmental Plating System for anterior cervical discectomy and fusion.
Viseon Gains FDA Clearance for Voyant Imaging for MIS Spine
Viseon announced FDA 510(k) clearance and initial clinical use of Voyant high-definition real-time imaging technology for minimally invasive spine surge...
4WEB Receives FDA Clearance for Cervical Stand Alone System
4WEB received FDA 510(k) clearance for its Cervical Spine Truss System-Stand Alone interbody.
ApiFix Gains FDA Approval for MID-C Scoliosis Treatment
ApiFix received Humanitarian Device Exemption approval to market the MID-C Minimally Invasive Deformity Correction system to treat adolescent idiopathic scol...
Cutting Edge Spine Gains FDA Clearance of EVOL-SI Joint Fusion
Cutting Edge Spine received FDA 510(k) clearance to market EVOL-SI, a sacroiliac joint fusion system.
Zimmer Biomet Gains FDA Approval for Tether Scoliosis Treatment
Zimmer Biomet received FDA approval for The Tether™, a vertebral body tethering system that offers an alternative to fusion in the treatment o...
Nexxt Spine Introduces Stand Alone Cervical Interbody
Nexxt Spine received FDA 510(k) clearance for the NEXXT MATRIXX® Stand Alone Cervical interbody fusion device.
Medicrea Gains FDA Clearance of TULIP GENESIS Top loading Screw
Medicrea received FDA clearance to market the TULIP GENESIS™ top loading screw, the final element in its UNiD™ ASI spine surgical plannin...
MiRus Gains FDA Clearance for CYGNUS Anterior Cervical Plate
MiRus received FDA 510(k) clearance to market the molybdenum alloy-based CYGNUS™ Anterior Cervical Plate.
FDA 510(k) Recap: Spinal Devices and Technologies from 1H19
By Julie A. Vetalice With the NASS 2019 Annual Meeting approaching, I thought it an ideal time to revisit spine products that have gained FDA 510(k) clearance in the first half of the year. (I’ve included booth numbers for companies that have already reserved their space at the ev...
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