bone screw News
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Silver Bullet Therapeutics Announces CE Mark Approval for the OrthoFuzIon Cannulated Bone Screw System
Silver Bullet Therapeutics, Inc., a privately-held medical device company, announced today that it has received CE Mark approval for the commercial sale of its antimicrobial OrthoFuzIon Cannulated Bone Screw System for orthopedic reduction and internal fixation (ORIF) procedures in the European Union. Over the coming months, the company plans to launch the product to selected European markets. ...
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Silver Bullet Therapeutics Secures CE Mark Approval for Revolutionary New Antimicrobial Bone Screw System
Silver Bullet Therapeutics, Inc., a privately-held medical device company, announced today that it has received recommendation for CE Mark approval for the commercial sale of its antimicrobial OrthoFuzIon™ Bone Screw System in the European Union for orthopedic reduction and internal fixation procedures anywhere in the body. Over the next few months, Silver Bullet will be finalizing launch ...
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Silver Bullet Therapeutics Announces Allowance of Two New Patents and Commercial Availability of the OrthoFuzIon Antimicrobial Bone Screw System
Silver Bullet Therapeutics, Inc., a privately-held medical device company, announced today that the U.S. Patent and Trademark Office allowed two new patents that include, COATINGS FOR THE CONTROLLABLE RELEASE OF ANTIMICROBIAL METAL IONS and BONE IMPLANT AND SYSTEMS THAT CONTROLLABLY RELEASES SILVER. The Company also announced that they will make the OrthoFuzIon Antimicrobial Bone Screw System ...
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Silver Bullet Therapeutics Reports Results of OrthoFuzIon Antimicrobial Bone Screw Testing Against the Top Six CDC Antibiotic Resistant “Superbugs”
Silver Bullet Therapeutics, Inc., a privately held medical device company that has developed an antimicrobial technology for implantable medical devices such as orthopedic bone screws, reported today the results of a study testing the “Time Kill” and “Adherence” effectiveness of its CE-marked OrthoFuzIon® Antimicrobial Bone Screw against the Top Six CDC ...
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ASTM F1839 - 08e2 standard specification for rigid polyurethane foam for use as a standard material for testing orthopedic devices and instruments
This specification covers rigid polyurethane foam blocks or sheets recommended for use as a standard material for mechanical testing using orthopedic devices and instruments. Although the physical properties of the foam are in the order of those reported for human cancellous bones, these materials are not intended for ...
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Silver Bullet Therapeutics Announces Allowance of Patent # 9,248,254
Silver Bullet Therapeutics, Inc., a privately-held medical device company committed to the development of antimicrobial medical devices, announced today that the U.S. Patent and Trademark Office allowed a new patent, BONE IMPLANTS FOR THE TREATMENT OF INFECTION. The company also announced that it has made an expedited CE Mark filing for a significantly expanded OrthoFuzIon Antimicrobial Bone ...
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Silver Bullet Therapeutics Announces Issuance of U.S. Patent No. 8,999,367 for Bioabsorbable Substrates That Controllably Release Metal Ions
Silver Bullet Therapeutics, Inc., a privately-held medical device company, announced today that the U.S. Patent and Trademark Office issued Patent No. 8,999,367 as a continuation of patent No. 8,927,004 that significantly enhances the claims for the release of antimicrobial metal ions to prevent infection. Paul Chirico, President and CEO of Silver Bullet Therapeutics stated, “We take a lot ...
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gammaCore Sapphire Non-Invasive Vagus Nerve Stimulator (nVNS) Receives Unique National Product Code Number by the Belgian Pharmaceutical Association
electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a commercial-stage bioelectronic medicine company, today announced that gammaCore Sapphire has been issued a National Code Number (CNK) in Belgium. CNK numbers are unique product code identifiers allocated by the Belgian Pharmaceutical Association (APB) for products and medicines commercially available from pharmacies throughout ...
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electroCore, Inc. Announces Distribution Agreement with Joerns Healthcare, LLC
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, announced today that gammaCore Sapphire™, the first and only FDA-cleared, non-invasive device to treat and prevent multiple types of headache pain via the vagus nerve, will be distributed and billed exclusively by Joerns Healthcare, LLC (Joerns) within selected managed care health systems. ...
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electroCore, Inc. Announces gammaCore Non-Invasive Vagus Nerve Stimulator Available Through National Spine and Pain Centers
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that the gammaCore Sapphire™ non-invasive vagus nerve stimulator (nVNS) will be available for purchase through many of the more than 130 National Spine and Pain Centers (NSPC) affiliated locations across the United States for patients suffering from pain associated with different forms of ...
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electroCore, Inc. Announces Study of gammaCore Sapphire for the Treatment of Post-COVID Syndrome
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced Mayo Clinic is initiating an investigator-initiated study to assess the efficacy of gammaCore Sapphire non-invasive vagus nerve stimulation (nVNS) in patients with post-COVID syndrome. Post-COVID syndrome, also known as Long COVID, is a collection of symptoms that persist greater than 28 days ...
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ASTM F1541 - 02(2011) standard specification and test methods for external skeletal fixation devices
A1.4.1 The purpose of this classification is to establish a consistent terminology system by means of which these ESFD configurations can be classified. It is anticipated that a companion testing standard using this classification system will subsequently be developed. 1. Scope 1.1 This specification provides a characterization of the design and mechanical function of ...
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gammaCore Non-Invasive Vagus Nerve Stimulation (nVNS) Improves Neurobehavioral Outcomes in a Model of Traumatic Brain Injury
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced data from an oral presentation at Neurocritical Care Society’s (NCS) 20th Annual Meeting held in San Antonio, Texas on October 17 – 21, 2022 on the possible role of gammaCore (nVNS) in the acute treatment of Traumatic Brain Injury (TBI). The presentation is being given by Dr. Afshin ...
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gammaCore (Non-Invasive Vagus Nerve Stimulation; nVNS) Reduces Symptoms of Acute Withdrawal in Patients with Opioid Use Disorder
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the publication of a peer reviewed manuscript, Transcutaneous Cervical Vagus Nerve Stimulation Reduces Behavioral and Physiological Manifestations of Withdrawal in Patients with Opioid Use Disorder: A Double-Blind, Randomized, Sham-Controlled Pilot Study in the journal, Brain Stimulation. The ...
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Empirical Spine Receives FDA Breakthrough Device Designation for the LimiFlex Device Targeting Degenerative Spondylolisthesis
Empirical Spine, Inc., a company developing advanced solutions for the surgical treatment of spinal disorders, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) for its LimiFlex™ Paraspinous Tension Band. In doing so, the FDA has determined that LimiFlex™ holds the potential to offer significant advantages over ...
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Empirical Spine Presents Data from Study of the LimiFlex Tension Band at the Society for Minimally Invasive Spine Surgery (SMISS) Annual Forum 2021
Empirical Spine, Inc., a Silicon-Valley based medical technology company, announced today that data from the IDE study of the company’s LimiFlex Tension Band for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis, was presented at the Society for Minimally Invasive Spine Surgery (SMISS) Annual Forum 2021. The SMISS Annual Forum took place from October 28 ...
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FDA Accepts & Closes Empirical Spine`s Limiflex PMA Module II as a Motion-Preserving Alternative to Lumbar Fusion
Empirical Spine, Inc., a medical device company creating a new class of spinal implant that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life, recently had its Premarket Approval (PMA) Module II accepted and closed by the US Food & Drug Administration (FDA), an important milestone in the commercial approval process for its ...
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Empirical Spine Submits PMA Module II for Limiflex as a New Motion-Preserving, Minimally Invasive Standard in Spine Surgery
Empirical Spine, Inc., a medical device company creating a new class of spinal implant that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life, recently submitted Premarket Approval (PMA) Module II in the US Food & Drug Administration (FDA) approval process for its LimiFlex™ Dynamic Sagittal Tether™ (DST). LimiFlex is ...
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Empirical Spine Advances LimiFlex as a New Motion-Preserving, Minimally Invasive Standard in Spine Surgery
Empirical Spine, Inc., a medical device company creating a new class of spinal implant that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life, achieved several clinical, reimbursement and regulatory milestones in the past 12 months that are moving its LimiFlex™ Dynamic Sagittal Tether™ (DST) closer to market in the US. The ...
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Nanovis Announces Commercial Launch of New Nanosurface Technology on Spinal Interbody Implants
CARMEL, Indiana. (July 30, 2019) – Nanovis today announced the commercial launch of its bioceramic nanotube enhanced FortiCore interbodies following a successful alpha launch. The FortiCore interbodies are designed with a unique, proprietary, patent protected bio-ceramic enhanced titanium nanotube surface. The nanotubes are applied to a deeply porous, fully interconnected titanium ...
By Nanovis
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