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    Breaking News

    FDA OKs CoreLink's F3D-C2 Stand-Alone Cervical Spine System

    Additively manufactured spacer has two bone screw anchors secured by a locking mechanism printed within the cage.

    FDA OKs CoreLink
    Image courtesy of Business Wire.
    Related CONTENT
    • Carbon22 Receives FDA 510(k) Clearance for FusionFrame Ring Lock System
    • FDA OKs Conformis' Cordera Hip System
    • FDA Clears Life Spine's SI Joint Revision Offering
    • FDA OKs RTI Surgical's Dynamic Active Compression Plate
    • Spineology Announces FDA Grant of Interbody Fusion System
    Business Wire06.30.20
    CoreLink LLC, a designer and manufacturer of spinal implant systems, announced the commercial launch and 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the F3D-C2 Stand-alone Cervical System.
     
    The system is comprised of an additively manufactured spacer with two bone screw anchors secured by a locking mechanism printed within the cage. Stand-alone cervical devices eliminate the need for a supplemental fixation plate, making anterior cervical discectomy and fusion (ACDF) procedures easier and faster to complete.
     
    Patented and proven 3D printed Mimetic Metal technology is incorporated into the spacer to emulate key characteristics of natural bone. The technology provides lower stiffness than machined titanium and the reduced implant density minimizes imaging artifact. Comprehensive instrumentation allows the device to be placed using freehand or guided techniques and modular guides facilitate working under a microscope.
     
    “The F3D-C2 Stand-alone Cervical System features the only 3D printed spine technology with both a trabecular structure and directional support lattices designed to allow for fusion throughout the entire implant,” said Jay Bartling, CEO of CoreLink. “Despite the challenges that have occurred in our industry recently, we have continued aggressively investing in new product development. We are committed to growing with our surgeon and distributor partners and expect several additional product launches this year.”
     
    The F3D-C2 Stand-alone Cervical System will be available in multiple footprints, heights, and lordotic angles. The system is designed and manufactured at CoreLink in St. Louis, MO.
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    Spineology Announces FDA Grant of Interbody Fusion System Spineology Announces FDA Grant of Interbody Fusion System
    FDA Approval for Simplify Medical’s 1-Level Disc FDA Approval for Simplify Medical’s 1-Level Disc
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    FDA Grants Breakthrough Device Designation to Novopedics’ MeniscoFix FDA Grants Breakthrough Device Designation to Novopedics’ MeniscoFix
    FDA Clears KA Imaging’s Portable Dual-Energy X-Ray Detector FDA Clears KA Imaging’s Portable Dual-Energy X-Ray Detector
    FDA Grants CTL Amedica 510k Clearance for MONDRIAN LIF Cage System FDA Grants CTL Amedica 510k Clearance for MONDRIAN LIF Cage System
    FDA OKs SurGenTec FDA OKs SurGenTec's OsteoFlo NanoPutty Quadphasic Synthetic Bone Graft
    First 3D Printed HAnano Surface Modified Implant Gets FDA Approval First 3D Printed HAnano Surface Modified Implant Gets FDA Approval
    MCRA Hires Former FDA Associate Director to Expand Neurology Franchise MCRA Hires Former FDA Associate Director to Expand Neurology Franchise
    IlluminOss Earns FDA Nod for Use in Fibula Fractures IlluminOss Earns FDA Nod for Use in Fibula Fractures
    Safe Orthopaedics Receives FDA 510(k) Approval for Second Generation of SteriSpine PS Safe Orthopaedics Receives FDA 510(k) Approval for Second Generation of SteriSpine PS

    Related Breaking News

    • Spine/Neurology
      ChoiceSpine

      ChoiceSpine's Tiger Shark Cervical Spacer Earns Additional 510(k)

      Adds additional footprint sizes that boost the ability to treat a wider variety of patient anatomies.
      Sam Brusco, Associate Editor 01.27.21

    • Spine/Neurology
      FDA Green Lights Inspired Spine

      FDA Green Lights Inspired Spine's Trident SI Joint Screw System

      Simplified kit replaces the multiple component instrument trays currently used in other SI Fusion systems.
      Sam Brusco, Associate Editor 01.27.21

    • FDA Clears Method to Extract Bone Measurements From X-Rays

      FDA Clears Method to Extract Bone Measurements From X-Rays

      The solution addresses the logistical bottleneck spurred by unnecessary implants being delivered to each surgery.
      Michael Barbella, Managing Editor 01.27.21


    • Spine/Neurology
      Spinal Elements

      Spinal Elements' Lucent XP-Curved Expandable TLIF Gains FDA Nod

      Fifth expandable device in the company's MIS Ultra suite.
      Sam Brusco, Associate Editor 01.26.21

    • Trauma/Sports
      FDA OKs OrthoSpin

      FDA OKs OrthoSpin's 2nd Gen Robotic, Digital External Fixation System

      The Generation 2 system is more user-friendly, covers all strut range sizes, and is 20 percent lighter.
      Sam Brusco, Associate Editor 01.26.21

    • Materials
      Nextremity Solutions Enters Supply Agreement with Fort Wayne Metals

      Nextremity Solutions Enters Supply Agreement with Fort Wayne Metals

      Gains access to a specialty Magnesium-based alloy for use in orthopedic implants.
      Charles Sternberg, Assistant Editor 01.26.21


    • osteolabs Closes Second Financing Round of Nearly 1.6 Million Euros

      osteolabs Closes Second Financing Round of Nearly 1.6 Million Euros

      Company to use funds for expansion purposes.
      Michael Barbella, Managing Editor 01.26.21

    • Spine/Neurology
      First Patient Implanted With NEXXT MATRIXX SA Cervical Turn-Lock System

      First Patient Implanted With NEXXT MATRIXX SA Cervical Turn-Lock System

      The product is designed to eliminate the need for traditional plate and screw fixation.
      Michael Barbella, Managing Editor 01.25.21

    • Cretex Companies CEO Steps Down

      Cretex Companies CEO Steps Down

      Jeff Wollerman will succeed Lynn Schuler as CEO of the company.
      Charles Sternberg, Assistant Editor 01.22.21


    • Conformis Enters Development & Supply Agreement with SITES Medical

      Conformis Enters Development & Supply Agreement with SITES Medical

      Will incorporate SITES Medical’s OsteoSync Ti Technology into future Conformis total knee replacement products.
      Charles Sternberg, Assistant Editor 01.22.21

    • Sectra, RSA Biomedical Sign Distribution Agreement for Implant Stability Tool

      Sectra, RSA Biomedical Sign Distribution Agreement for Implant Stability Tool

      The Sectra CTMA is part of the orthopedic module of Sectra’s enterprise imaging solution.
      Michael Barbella, Managing Editor 01.22.21

    • Imaging
      Siemens Healthineers’ DR Systems Cleared by FDA

      Siemens Healthineers’ DR Systems Cleared by FDA

      New user interface helps technologists of every experience level achieve high image quality.
      Charles Sternberg, Assistant Editor 01.21.21


    • Former Medtronic Exec Appointed Zimmer Biomet

      Former Medtronic Exec Appointed Zimmer Biomet's Chief Transformation Officer

      Ellison (Ellie) Humphrey will be responsible for connecting key initiatives and a higher level, more integrated transformation strategy.
      Sam Brusco, Associate Editor 01.21.21

    • Spine/Neurology
      SeaSpine Launches Regatta Lateral Plates

      SeaSpine Launches Regatta Lateral Plates

      LLIF fixation system allows for multiple plating options, including one, two, and four-hole plates.
      GlobeNewswire 01.21.21

    • Spine/Neurology
      RIVANNA Launches Second-Generation Accuro With Thoracic Functionality

      RIVANNA Launches Second-Generation Accuro With Thoracic Functionality

      Real-time needle guidance for paramedian epidural and spinal anesthesia maximizes image guidance efficiency.
      RIVANNA 01.21.21


    Trending
    • Conformis Enters Development & Supply Agreement With SITES Medical
    • Spinal Elements' Lucent XP-Curved Expandable TLIF Gains FDA Nod
    • Nextremity Solutions Enters Supply Agreement With Fort Wayne Metals
    • Mini MRI For Hand And Wrist Imaging Can Be Used Nearly Anywhere
    • First Patient Implanted With NEXXT MATRIXX SA Cervical Turn-Lock System
    Breaking News
    • ChoiceSpine's Tiger Shark Cervical Spacer Earns Additional 510(k)
    • FDA Green Lights Inspired Spine's Trident SI Joint Screw System
    • FDA Clears Method to Extract Bone Measurements From X-Rays
    • Spinal Elements' Lucent XP-Curved Expandable TLIF Gains FDA Nod
    • FDA OKs OrthoSpin's 2nd Gen Robotic, Digital External Fixation System
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Making the Grade: Orthopedic Materials Spotlight
    • Mending Mishaps: A Trauma Technology Overview
    • Life, Interrupted: The 2020 Year in Review
    • View More >

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