May 06, 2015–Rockaway, NJ – LinkSPINE, a company focused upon simple, less invasive implants and techniques for spinal surgery, is pleased to announce FDA (510)k Clearance of FacetLINK. FacetLINK uses two screws and a novel plated cross-connector assembly to stabilize the spine following a tissue-sparing midline or microsurgical decompression. The plate assemblies are available in […]
FDA
Medtronic Receives FDA Clearance for ZEVO(TM) Anterior Cervical Plate System
DUBLIN – May 4, 2015 -Medtronic plc (NYSE: MDT) announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the ZEVO(TM) Anterior Cervical Plate System. This system is now commercially available for the treatment of cervical degenerative disc disease, trauma, tumors, deformity, pseudoarthrosis, and/or failed previous fusions. The ZEVO […]
Simplify™ Cervical Artificial Disc Receives IDE Approval
MOUNTAIN VIEW, Calif., March 18, 2015 /PRNewswire/ — Simplify Medical, Inc. is pioneering disc arthroplasty with the non-metal, MRI friendly SimplifyTM cervical artificial disc. The Company announced today that it received Investigational Device Exemption (IDE) approval from the Food and Drug Administration (FDA) to initiate its clinical trial comparing Simplify Disc with anterior cervical discectomy […]
Life Spine® Announces FDA Clearance of Forty Transition Connector Implants to Thoracolumbar and Cervical Systems
HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to forty implant additions to the CONQUEST®, AVATAR®, and NAUTILUS®Thoracolumbar Screw Systems and SOLSTICE® Occipito-Cervico-Thoracic System. “The addition […]
joimax Receives 510(k) Clearance for Percusys Pedicle Screw-Rod System
IRVINE, Calif., March 4, 2015 (GLOBE NEWSWIRE) — The German company joimax®, developer of technologies and training methods for minimally invasive endoscopic spinal surgery, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Percusys® percutaneous pedicle screw-rod system. The patented Percusys system is a multi-functional implant […]
VertiFlex®, Inc. Announces FDA Advisory Panel Support for the Superion® Interspinous Spacer
SAN CLEMENTE, CALIF. — VertiFlex®, Inc., a leading innovator of advanced minimally invasive interventions for spinal stenosis, announced today that the U.S. Food and Drug Administration’s (FDA) Orthopedic and Rehabilitation Devices Advisory Panel has voted strongly in support of the PreMarket Approval application for the company’s Superion® Interspinous Spacer System. The Panel voted that Superion […]
Medtronic Receives Expanded Indications of the VERTEX® Reconstruction System
DUBLIN – Feb. 16, 2015 – Medtronic plc (NYSE: MDT), today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for expanded indications of the VERTEX®Reconstruction System. The new clearance for the VERTEX® family of products allows for lateral mass and pedicle screws to be used as a form of […]
Amedica Submits 510(k) Application to FDA for Composite Spinal Interbody Spacers with Porous Silicon Nitride Center
Amedica Corporation (Nasdaq:AMDA), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, announced today that it has filed a submission for 510(k) clearance of the Valeo C Interbody with CsC Osteo-Conductive Scaffolding (“Valeo CCsC”) with the U.S. Food and Drug Administration (“FDA”) relating to its composite silicon nitride spinal interbody devices. […]
Titan Spine Receives FDA Clearance to Launch Endoskeleton® TCS Device for Cervical Fusion with Integrated Fixation
MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to commercially release its Endoskeleton® TCS, an interbody fusion device for the cervical spine with integrated fixation. The Endoskeleton® TCS represents […]
Z-Medical® received FDA 510(k) clearance for their MIS Z-Pedicle Screw System
The MIS Z-Pedicle Screw System offers the surgeons an ideal solution for their indication specific needs. Only one instrument set and the innovative screw design enable the surgeon to address the most common pathologies.The system was designed for a minimally-invasive approach for less tissue disruption, blood loss and trauma. It offers an optimal intra-operative control […]
Precision Spine™ Records Fifth Consecutive Year of Double-Digit Growth; Announces FDA Clearance for Reli™ SP Spinous Plating System and Expanded Indications for Reform® Pedicle Screw System
PARSIPPANY, N.J.–(BUSINESS WIRE)–Precision Spine, Inc. announced that sales results for the year ending December 31, 2014 gave the company its fifth consecutive year of double-digit growth. The company indicated that fourth quarter 2014 sales represented a 45% increase over fourth quarter 2013. Full year 2014 sales increased 26% over the prior year. The company expanded […]
SpineGuard receives FDA clearance to market its PediGuard products for Minimally Invasive Surgery (MIS)
PARIS and SAN FRANCISCO (Feb. 3, 2015) – SpineGuard (FR0011464452 – ALSGD) announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its PediGuard products for Minimally Invasive Surgery (MIS).“This is an especially important regulatory milestone for SpineGuard, as it will allow us to promote the use […]
SpineGuard receives FDA clearance to market its PediGuard products for Minimally Invasive Surgery (MIS)
PARIS and SAN FRANCISCO (Feb. 3, 2015) – SpineGuard (FR0011464452 – ALSGD) announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its PediGuard products for Minimally Invasive Surgery (MIS).“This is an especially important regulatory milestone for SpineGuard, as it will allow us to promote the use […]
Spinal Elements®, Inc. Announces Clearance and Impending Launch of Cervical Ti-Bond® Coated Implants
Carlsbad, CA (PRWEB) January 27, 2015–Spinal Elements http://www.spinalelements.com, a spine technology company, today announced that they recently received clearance through the United States Food and Drug Administration for a full line of interbody devices with Ti-Bond® coating for use in the cervical spine. Spinal Element’s Ti-Bond coating consists of titanium with random, unconnected pores that […]
Intelligent Implant Systems Gains FDA Approval for the Revolution Spinal System™ with Disposable Instrumentation Kit from ECA Medical Instruments
Charlotte, NC (PRWEB) January 16, 2015–Intelligent Implant Systems, LLC (IIS) announced today its novel Revolution Spinal System™ for correction of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine has received 510(k) approval for market release by the US Food and Drug Administration (FDA). The pre-sterile implant system and single-procedure instrument […]
Spinal Simplicity Announces FDA 510(k) Clearance of the Minuteman Lateral Percutaneous Interlaminar Fusion Device
OVERLAND PARK, Kan., Jan. 12, 2015 (GLOBE NEWSWIRE) — via PRWEB – Spinal Simplicity, LLC, a spinal device company dedicated to the creation of innovative simple solutions to treat complex spinal disorders, announced today that FDA granted 510(k) marketing clearance for the Minuteman system. The Minuteman, a pre-packaged sterile supplemental posterior fixation system, offers a […]
VertiFlex®, Inc. Announces FDA Advisory Panel Meeting for the Superion® Interspinous Spacer System
SAN CLEMENTE, Calif.–(BUSINESS WIRE)–VertiFlex®, Inc., a leading innovator of advanced minimally invasive interventions for spinal stenosis, announced today the U.S. Food and Drug Administration (FDA) has scheduled an Orthopedic and Rehabilitation Devices Advisory Panel meeting on February 20, 2015 to discuss, make recommendations, and vote on the company’s Premarket Approval (PMA) Application for the Superion® […]
DePuy Synthes Spine received 510(k) approval to market the VEPTR®/VEPTR II™ Vertical Expandable Prosthetic Titanium Rib Devices for the treatment of Thoracic Insufficiency Syndrome (TIS) in children.
RAYNHAM, MA – Dec. 4, 2014 – DePuy Synthes Spine* today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the VEPTR®/VEPTR II™ Vertical Expandable Prosthetic Titanium Rib Devices for the treatment of Thoracic Insufficiency Syndrome (TIS), a rare congenital condition where severe deformities of the chest, spine […]
Solvay’s Zeniva PEEK takes on titanium in spinal implant device
November 17th, 2014, (PlasticsToday)–Chalk up another victory for polyetheretherketone (PEEK) in the metal replacement sweepstakes. Thompson MIS (Salem, NH), a supplier of minimally invasive spinal implants and delivery systems, has received 510(k) clearance from FDA for its BoneBac TLIF spacer made of Zeniva PEEK resin from Solvay Specialty Polymers (Alpharetta, GA). Solvay made the announcement […]
Solvay’s Zeniva PEEK takes on titanium in spinal implant device
November 17th, 2014, (PlasticsToday)–Chalk up another victory for polyetheretherketone (PEEK) in the metal replacement sweepstakes. Thompson MIS (Salem, NH), a supplier of minimally invasive spinal implants and delivery systems, has received 510(k) clearance from FDA for its BoneBac TLIF spacer made of Zeniva PEEK resin from Solvay Specialty Polymers (Alpharetta, GA). Solvay made the announcement […]
Aurora Spine Receives FDA 510(k) Clearance for Pre-Packaged Sterile ZIP 51™ MIS Interspinous Fixation Implant
CARLSBAD, CALIFORNIA–(Marketwired – Nov. 18, 2014) – Aurora Spine Corporation (TSX VENTURE:ASG) announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ZIP 51™, Aurora Spine’s slimmest minimally invasive interspinous fixation implant for spinal fusion.The ZIP 51 was developed as an alternative to pedicle screw fixation and designed for […]
FDA Clears World’s First Patient-Specific Spinal Rod
NEW YORK & LYON, France–(BUSINESS WIRE)–The MEDICREA Group (Alternext Paris: FR0004178572 – ALMED), a company that specializes in the development of personalized implants produced for a patient’s specific need in the treatment of spinal pathologies, today announced the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for UNiDTM, the world’s […]
Precision Spine™ Announces 510(k) Clearance of the VAULT®-C Anterior Cervical Interbody Fusion Device
PARSIPPANY, N.J.–(BUSINESS WIRE)–Precision Spine, Inc. announced that it recently received 510(k) clearance and initiated the launch of its VAULT-C Anterior Cervical Interbody Fusion Device.VAULT-C represents a significant addition to the Precision Spine cervical product portfolio, and joins an array of recently introduced advanced spinal solutions from the company. The new VAULT-C offers the versatility so […]
Precision Spine™ Announces 510(k) Clearance of the VAULT®-C Anterior Cervical Interbody Fusion Device
PARSIPPANY, N.J.–(BUSINESS WIRE)–Precision Spine, Inc. announced that it recently received 510(k) clearance and initiated the launch of its VAULT-C Anterior Cervical Interbody Fusion Device.VAULT-C represents a significant addition to the Precision Spine cervical product portfolio, and joins an array of recently introduced advanced spinal solutions from the company. The new VAULT-C offers the versatility so […]
VEXIM to Initiate Clinical Study to Support Planned 510(k) Application to Market SpineJack® in the United States
TOULOUSE, France–(BUSINESS WIRE)–Regulatory News: VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM / Eligible PEA-PME), a medical device company specializing in the minimally invasive treatment of vertebral fractures, today announced it will initiate a new clinical study that will support its planned application for 510(k) regulatory clearance to market SpineJack® in the U.S. The Company expects to complete the […]
RTI Surgical™ Receives Letter From FDA on map3® Cellular Allogeneic Bone Graft
ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical Inc. (RTI) (Nasdaq: RTIX), a global surgical implant company, received a letter from the Food and Drug Administration (FDA) regarding the company’s map3® cellular allogeneic bone graft. The letter addresses some technical aspects of the processing of the map3 allograft, as well as language included in the map3 website.“We have carefully […]
Life Spine® Announces FDA Clearance of LONG BOW™ Expandable Lateral Interbody System
HOFFMAN ESTATES, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the LONG BOW Expandable Lateral Interbody System.The innovative LONG BOW Expandable Lateral Interbody System is the […]