RAYNHAM, Mass., Jan. 26, 2017 /PRNewswire/ — DePuy Synthes*, part of the Johnson & Johnson Family of Companies, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VIPER® and EXPEDIUM® Fenestrated Screw Systems. When used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the screws are intended to restore the […]
FDA
Implanet announces global marketing clearance of the new JAZZ FRAME®
Bordeaux, Boston, January 25, 2017: IMPLANET (Euronext: IMPL, FR0010458729, PEAPME eligible; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today announces that it has been given the green light by the American and European authorities, through FDA 510k clearance and CE marking, to market its new Jazz Frame® implant. JAZZ Frame® […]
Camber Spine Technologies Announces 510(k) Clearance For Their Siconus™ SI Joint Fixation System
WAYNE, Pa., Jan. 23, 2017 /PRNewswire/ — Camber Spine Technologies, today announced that it has received 510(k) clearance for their Siconus™ SI Joint Fixation System. Siconus™ becomes the second product in the Camber Spine Technologies portfolio to treat sacroiliac disease, as a complement to the Prolix™ custom machined allograft implant. “The Siconus™ SI Fusion Screw System […]
Precision Spine® Announces 510(k) Clearance of the ShurFit® ACIF 2C System
PARSIPPANY, N.J.–(BUSINESS WIRE)–Precision Spine, Inc., a medical device company dedicated to Made-in-the-USA manufacturing, has announced today that it recently received 510(k) clearance of its ShurFit® ACIF 2C Anterior Cervical Interbody System, which is made from medical grade polyetheretherketone (Peek Optima, LT1) and coated with both commercially pure Titanium (Ti) and Hydroxyapatite (HA). The innovative combination […]
SpineGuard® receives FDA clearance to market its DSG™ integration module for making pedicle screws “smart”
PARIS and SAN FRANCISCO, January 16, 2017 – SpineGuard (FR0011464452 – ALSGD), an innovative company that develops and markets disposable medical devices to make spine surgery safer, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new DSG™ (Dynamic Surgical Guidance) integration module to be used in […]
Medicrea Announces 510(k) Submission for FDA Clearance of Proprietary 3D-Printed Titanium Spinal Interbody Devices
LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Alternext Paris: FR0004178572 – ALMED), worldwide leader pioneering the development and manufacture of personalized analytical services and implant solutions for the treatment of complex spinal conditions, today announced the filing of its 510(k) submission to the U.S. Food and Drug Administration (FDA) for approval of the Company’s […]
Amedica Announces Positive Scientific Data and Re-files FDA Submission
SALT LAKE CITY, UT–(Marketwired – Dec 19, 2016) – Amedica Corporation (NASDAQ: AMDA), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, announced encouraging results from a recent study showing rapid bone growth into porous silicon nitride. Explants of the company’s porous silicon nitride from a large-animal model demonstrated bone healing into […]
FDA Clearance for joimax® Vaporflex® and Legato® Electrosurgical Probes
IRVINE, Calif. & KARLSRUHE, Germany–(BUSINESS WIRE)–joimax®, the global acting German developer and marketer of technologies and training methods for endoscopic minimally-invasive spinal surgery, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Vaporflex® and Legato® electrosurgical probes with radiowave technology for open and endoscopic spine surgery. The joimax® Electrosurgical […]
G Surgical Announces FDA Clearance and Launch of the MARKSMAN MIS® Spine System
Boulder, CO (September 2, 2016)–G Surgical, a privately held medical device company offering innovative spinal implants, announced that it has received 510(k) clearance from the United States Food and Drug Administration to market their MARKSMAN MIS® Spine System. Don Grafton, President and CEO of G Surgical, comments, “We are excited to strengthen our portfolio by […]
Spinal Elements® Receives 510(k) Clearance for Interspinous Process Device
CARLSBAD, CA (PRWEB) AUGUST 17, 2016–Spinal Elements, a spine technology company, announced that they have received 510(k) clearance from the United States Food and Drug Administration (FDA) to market an interspinous process device. Interspinous process devices are placed between the spinous processes of the spine and provide support and fixation while a spinal fusion forms. […]
Spinal Elements® Receives 510(k) Clearance for Expandable Interbody Device
Spinal Elements, a spine technology company, announced that they have received 510(k) clearance from the United States Food and Drug Administration (FDA) to market a line of expandable interbody fusion devices. A comprehensive list of items were a part of this clearance, including expandable interbody devices for posterior, anterior, and lateral access to the lumbar […]
Tyber Medical Expands FDA 510(k) Clearance Of Headed And Snap-Off Screws
MORRISTOWN, N.J., June 14, 2016 /PRNewswire/ — Tyber Medical, LLC, a company focused on providing rapid private label commercialization with innovative orthopedic and spine devices including bioengineered surfaces, announces FDA 510K clearance of their headed and snap-off screws systems. Tyber Medical’s private label partners now have access to the most extensive range of trauma screws […]
ChoiceSpine Titanium Interbody 510(k)
KNOXVILLE, TN, June 7, 2015 – ChoiceSpine, a Knoxville, TN based spinal implant company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market titanium lumbar interbody fusion devices. ChoiceSpine plans to offer titanium interbody devices for traditional PLIF (Posterior Lumbar Interbody Fusion) and TLIF (Transforaminal Lumbar Interbody […]
Orthofix Announces 510(k) Clearance and US Limited Market Launch of FORZA PTC
LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX), a diversified, global medical device company, today announced the 510(k) clearance and U.S. limited market launch of the FORZA® PTC™ (Peek Titanium Composite) Spacer System. Designed and manufactured using a proprietary method, FORZA PTC spacers combine PEEK and 3D printed titanium end plates into a single porous interbody solution […]
Camber Spine Technologies Receives FDA Clearance for ENZA™ Zero Profile Alif Device
WAYNE, Pa., May 5, 2016 – Camber Spine Technologies, a medical device company focused on designing, developing and commercializing innovative and proprietary musculoskeletal implant systems, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ENZA™ Zero Profile Anterior Interbody Fusion (ALIF) system, a unique, minimally invasive […]
Intelligent Implant Systems Receives 510(k) Clearance for Two-Level Revolution
Intelligent Implant Systems announced today that the two-level components for the Revolution™ Spinal System were cleared by the FDA via 510(k) for sale in the United States. These components expand the capabilities of the system and allow Revolution™ to be utilized for two-level posterior thoraco-lumbar fusions. With one-level sales beginning in October of 2015, the […]
FDA Clears Xspan Laminoplasty Fixation System
Xtant Medical Holdings, Inc. (NYSE: XTNT) announced that its wholly owned subsidiary, X-spine Systems, received FDA clearance of the Xspan™ Laminoplasty Fixation System. The Xspan™ System represents the latest generation of laminoplasty fixation. Spinal laminoplasty is a surgical procedure performed to remove pressure from the spinal cord. Xtant Medical estimates the worldwide market for laminoplasty […]
Titan Spine Executive Appointed to Executive Operations Committee for FDA-Sponsored MDEpiNet
MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced the appointment of Jeff Dunkel, Titan Spine Vice President, Strategic Partnering, to the Executive Operations Committee of the Medical Device Epidemiology Network Initiative (MDEpiNet). The initiative is a collaborative program of the FDA’s Center for […]
Life Spine Announces FDA Clearance of PROLIFT
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 the PROLIFT Expandable Interbody System. PROLIFT is the latest addition to the company’s best in class, patented […]
Stryker Receives FDA Clearance for Tritanium® PL Posterior Lumbar Cage
ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced that its Tritanium PL Posterior Lumbar Cage, an intervertebral body fusion device that aids in lumbar spinal fixation for patients with degenerative disc disease, has received 510(k) clearance from the U.S. Food and Drug Administration. The Tritanium PL posterior lumbar cages are constructed out of proprietary Tritanium technology […]
Wenzel Spine, Inc. Announces FDA Clearance to Launch VariLift
AUSTIN, Texas–(BUSINESS WIRE)–Wenzel Spine, Inc., a pioneer medical device company focused on providing minimally invasive, stand-alone alternatives to traditional spinal fusion, announced today that it received clearance from the U.S. Food and Drug Administration (FDA) to market VariLift®-LX as an interbody fusion device for stand-alone use in the lumbar spine. VariLift®-LX represents the next generation […]
K2M Receives CE Mark for Its Next-Generation RHINE(TM) Cervical Disc System
LEESBURG, Va., Jan. 21, 2016 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (Nasdaq:KTWO), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies and techniques, today announced it has received a CE Mark for the RHINE™ Cervical Disc System, allowing for sale and distribution of the product within […]
Centinel Spine™ Announces the FDA Clearance and First Implantation of ALTOS™
NEW YORK, Jan. 21, 2016 /PRNewswire/ — Centinel Spine, Inc., (Centinel Spine) announces the U.S. Food and Drug Administration (FDA) clearance of ALTOS™, a posterior cervical thoracic stabilization system indicated for use in either the lateral masses of the cervical spine or the pedicles of the cervical-thoracic spine. The first surgical implantation of the ALTOS […]
VGI Medical Announces FDA Clearance of the VerteLP® Lateral Lumbar Cage System
SAINT PETERSBURG, FLORIDA (PRWEB) JANUARY 19, 2016–VGI Medical, LLC, a privately held medical device company offering innovative spinal implants, announced that it has received 510(k) clearance from the United States Food and Drug Administration to market the VerteLP Lateral Lumber Cage System. VerteLP represents the latest of lateral lumbar fusion, featuring enhanced bi-cortical plating technology […]
MEDTECH Receives FDA Clearance for ROSA Spine
MONTPELLIER, France, Jan. 05, 2016 (GLOBE NEWSWIRE) — MEDTECH (Euronext, FR0010892950 – ROSA), a company specialized in designing, developing and marketing innovative surgical assistance robots, is pleased to announce that it has received 510K clearance from the United States Food and Drug Administration (FDA) to market the ROSA™ Spine robot in the United States of […]
DeGen Medical Receives Clearance of Latitude-C(TM) Cervical Interbody Spacer System
FLORENCE, S.C., Dec. 18, 2015 (GLOBE NEWSWIRE) — DeGen Medical has received clearance from the FDA for our cervical interbody fusion device – Latitude-C™ Cervical Interbody Spacer System. Latitude-C™ Cervical Interbody Spacer offers the surgeon a wide variety of materials based on patient needs – PEEK-OPTIMA®, Porous Titanium with PEEK, PEEK-OPTIMA® HA Enhanced, Titanium and […]
Life Spine® Announces FDA Clearance of GRUVE™ Anterior Cervical Plate System
December 17, 2015 —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 the GRUVE Anterior Cervical Plate System. The innovation of the GRUVE Anterior Cervical Plate […]