SAN FRANCISCO–(BUSINESS WIRE)–Providence Medical Technology, Inc. (PMT) today announced it received 510(k) clearance from the FDA for its PMT Cervical Cage. PMT Cervical Cage is a novel minimally-invasive implant and delivery system for cervical fusion procedures.PMT Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine […]
FDA
Spinal Elements®, Inc. Announces Licensing and 510(k) Product Clearance
CARLSBAD, Calif., May 29, 2013 /PRNewswire-iReach/ — Spinal Elements, a spine technology company, today announced that they have licensed a portfolio of patents essential for accessing the lumbar spine from a lateral approach and placing implants from that approach. The lateral approach to the spine provides the potential for less disruptive, minimally invasive surgical (MIS) […]
VESTAKEEP® PEEK-Based Spinal Implant Receives FDA 510(k) Approval
PARSIPPANY, N.J. — Xiphos™ ALIF, a VESTAKEEP® PEEK-based (polyetheretherketone) spinal implant developed by DiFusion Technologies, has received the U.S. Food and Drug Administration’s (FDA) 510(k) approval for use in Interbody Fusion Devices (IBF) devices.“DiFusion Technologies is very excited about the FDA 510(k) approval of the VESTAKEEP® PEEK-based Xiphos™ ALIF spinal implant,” said Derrick Johns, managing […]
Maxim Surgical achieves FDA clearance for new spinal implants
Maxim Surgical, a new designer and manufacturer of spinal implants, has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its new MaxFuse-C™ cervical interbody fusion system made of Zeniva® polyetheretherketone (PEEK) rods from Solvay Specialty Polymers. Zeniva® PEEK – part of Solvay’s line of Solviva® Biomaterials – has a modulus very […]
X-spine Announces FDA Clearance of New Spinal Implant System
MIAMISBURG, Ohio–(BUSINESS WIRE)–X-spine, a global leader in the design and manufacture of devices for the treatment of spinal disease, announces a new USFDA clearance for the Zygafix™ Facet Fusion System. The newly-cleared Zygafix™ system allows for fusion and stabilization of the facet joint (also termed the zygapophyseal joint) in eligible patients whom appropriate non-surgical treatment […]
Alphatec Holdings receives 510(k) clearance for interbody fusion device
The FDA has issued 510(k) clearance for Alphatec Holdings Inc. to market and sell its Alphatec Solus internal fixation anterior lumbar interbody fusion device in the United States.Featuring two counter-rotating titanium blades, which deploy into adjacent vertebrae on a zero-degree axis, locking the device in place, the anterior lumbar interbody fusion device has four points […]
X-spine Announces FDA Clearance of New Implant System
MIAMISBURG, Ohio, Mar 20, 2013 (BUSINESS WIRE) — X-spine, a global leader in the design and manufacture of devices for the treatment of spinal disease, announces a new USFDA clearance for the Silex(TM) sacroiliac (SI) joint fusion system.The newly-cleared Silex(TM) system allows for fusion and stabilization of the SI joint in eligible patients whom appropriate […]
Alphatec Spine Receives FDA 510(K) Market Clearance for Its Alphatec Solus
CARLSBAD, Mar 12, 2013 (GLOBE NEWSWIRE via COMTEX) — Alphatec Holdings, Inc. , the parent company of Alphatec Spine, Inc., a company with a mission to provide physician-inspired solutions for patients with spinal disorders, announced today that the Company has received clearance from the U.S. Food and Drug Administration (FDA) to market and sell its […]
Vertiflex®, Inc. Announces FDA Clearance of Two Key Additions to Technology Portfolio
SAN CLEMENTE, Calif. —VertiFlex®, Inc., a leading innovator of advanced minimally invasive spinal surgery technologies, today announced FDA 510(k) clearance of two new products to its portfolio: The Totalis™ Direct Decompression System and UniVise™ Spinous Process Fixation System.“These regulatory clearances represent important milestones for VertiFlex® as we rapidly expand our portfolio of innovative interspinous technologies,” […]
Alphatec gains 510(k) clearance for cervical interbody device, fixation system
Alphatec Holdings Inc. was granted 510(k) market clearance from the FDA for the Pegasus and the Illico FS Facet Fixation System, according to a company news release.The Pegasus is an anchored, anterior cervical interbody device which offers single-step deployment of the anchoring blades without impaction. The Illico FS Facet Fixation System is a new minimally […]
FDA gives Zimmer recall its most serious score
WASHINGTON — The Food and Drug Administration said Friday that more than 300 spinal surgical instruments recalled last week by Zimmer Holdings Inc. could potentially cause serious injury or death. Zimmer announced Dec. 20 it was recalling 315 Peek Ardis Inserters after reports that the devices could cause surgical delays and injury when used with […]
Precision Spine™ Announces FDA 510(k) Clearance for its Minimally Invasive Access System
PARSIPPANY, N.J.–(BUSINESS WIRE)–Precision Spine announced today that it received 510(k) clearance from the FDA on November 20, 2012 for its Mini-Max Minimally Invasive Access System.“The development of the Mini-Max Minimally Invasive Access System represents what we believe to be the next evolutionary step in the ongoing advancement of MIS spine procedures. I believe that the […]
Integra LifeSciences Receives FDA Clearance for Expanded Indication for Spinal Device
PLAINSBORO, N.J., Oct. 9, 2012 (GLOBE NEWSWIRE) — Integra® LifeSciences Holdings Corporation (Nasdaq:IART) today announced that the Food and Drug Administration (FDA) has approved an expanded indication for use of the Integra® Vu aPOD™ Prime Intervertebral Body Fusion Device (IBD) in anterior lumbar interbody fusion (ALIF) procedures. The new stand-alone indication includes four points of […]