55 results found.
      
PeekMed Gains FDA Clearance for Pre-Op Planning Software
PeekMed® received FDA 510(k) clearance to market its 3D pre-operative planning software.
NuVasive Gains FDA Clearance for Monolith Corpectomy
NuVasive received FDA 510(k) clearance to market an expanded indication for the Monolith® corpectomy system...
Nexxt Spine Launches SAXXONY Posterior Cervical Thoracic System
Nexxt Spine grows its fusion portfolio with launch of the SAXXONY® Posterior Cervical Thoracic system.
NuVasive Gains FDA Clearance for COHERE in XLIF
NuVasive received FDA 510(k) clearance for the COHERE® Porous PEEK™ device in eXtreme Lateral Interbody Fusion
Spinal Elements Receives Additional FDA 510(k) Clearance for Ti-Bond Coating Technology
Spinal Elements received additional FDA 510(k) clearance for claims related to the macro-, micro- and nano-surface structure of its Ti-Bond® surf...
Siemens Healthineers Gains FDA Clearance for Cios Spine Mobile C-Arm
Siemens Healthineers received FDA clearance to market Cios Spin, a mobile C-arm that provides interoper...
Innovasive Gains FDA Clearance for DualX Expanding Interbody
Innovasive received FDA 510(k) clearance to market the DualX™ titanium dual expanding interbody device for l...
OrthoPediatrics Gains FDA Clearance for Small Stature Scoliosis System
OrthoPediatrics received FDA 510(k) clearance to market the RESPONSE 4.5/5.0mm system to treat complex scoliosis...
How the EU’s MDR Will Impact Your Supply Chain
By Carolyn LaWell The forthcoming EU Medical Device Regulation will impact your supply chain, both in manufacturing and distribution. You must talk with your partners now to ensure that you possess the information you need from them—and they from you—to meet regulatory requi...
VISEON Gains FDA Clearance for Voyant Surgical Platform
Viseon received FDA 510(k) clearance to market the Voyant System for Minimally Invasive Spine Surgery access, visualizati...
SpineEX Gains FDA Clearance for Sagittae LLIF
SpineEX received FDA 510(k) clearance to market its Sagittae® expandable device for minimally invasive lateral lumbar in...
Alphatec Gains FDA Clearance for OsseoScrew
Alphatec received FDA 510(k) clearance to market the OsseoScrew® expandable pedicle screw. 
Baxter Receives FDA Clearance for ALTAPORE Bone Graft
Baxter was granted FDA 510(k) clearance to market ALTAPORE Bioactive Bone Graft as an autograft extender...
Renovis Surgical Receives FDA Clearance for Tesera X Lateral Interbody Fusion System
Renovis Surgical received FDA 510(k) clearance to market the Tesera® X Lateral Interbody Fusi...
Stryker Gains FDA Clearance for SpineJack Fracture Reduction
Stryker received FDA 510(k) clearance for the SpineJack® implantable reduction system to treat osteoporotic verte...
SpineVision Gains FDA Clearance, CE Mark for HEXANIUM TLIF Cage
SpineVision received FDA (510)k clearance and CE Mark approval for the 3D-printed HEXANIUM TLIF cage.
Captiva Spine Gains FDA Clearance for TowerLOX-EXT Tab Pedicle Screws
Captiva Spine announced FDA 510(k) clearance for the TowerLOX-EXT® MIS Extended Tab pedicle screw.
Genesys Spine Gains FDA Clearance for AIS-C Interbody System
Genesys Spine announced FDA 510(k) clearance and launch of the AIS-C Stand-Alone interbody system for cervical spine.
Captiva Spine Gains FDA Clearance for TirboLOX-L Cage
Captiva Spine announced FDA 510(k) clearance and launch of the TirboLOX-L 3D-printed titanium lumbar cage.
Eden Spine Gains FDA Clearance for SPHYNX Thoracolumbar Plate
Eden Spine received FDA 510(k) clearance to market the SPHYNX™ thoracolumbar locking plate.
Osseus Fusion Gains FDA Clearance for 3D-Printed Lumbar IBFs
Osseus Fusion Systems received FDA 510(k) clearance to market Aries 3D-printed lumbar interbody fusion devices.
CoreLink Gains FDA Clearance for Foundation 3D ALIF
CoreLink received FDA 510(k) clearance to market the Foundation™ 3D Anterior Lumbar Interbody Fusion...
OrthoPediatrics Announces Expanded Indication for FIREFLY Pedicle Screw Navigation
OrthoPediatrics announced an additional FDA 510(k) clearance for the FIREFLY® Pedicle Screw Navigation Guide t...
CarboFix Gains FDA Clearance for Pedicle Screw
CarboFix Orthopedics received FDA 510(k) clearance to market the CarboClear® Carbon Fiber Pedicle Screw to treat oncological pati...
NuVasive Gains FDA Clearance for Pulse Surgical Automation
NuVasive received FDA 510(k) clearance to market Pulse™ surgical automation, the foundation fo...
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