MORRISTOWN, N.J., Aug. 19, 2015 /PRNewswire/ — Tyber Medical, LLC, a privately held medical device company focused on developing innovative orthopedics and spine devices for private label opportunities, announces FDA 510(k) clearance for TyWedge™ Opening Osteotomy Wedge Systems, a titanium plasma sprayed PEEK wedge implant. TyPEEK®, a proprietary titanium plasma sprayed PEEK implant specifically indicated […]
FDA
Aurora Spine Receives CE Mark Approval for Sterile-Packed TiNano(R) Coated Interbody Systems
CARLSBAD, Calif., Aug. 18, 2015 (GLOBE NEWSWIRE) — Aurora Spine Corporation (TSX-V:ASG) announced today that it has received confirmation of CE Mark issuance for the full line of its TiNano® sterile-packed titanium coated spinal fusion implants made of PEEK thermoplastic material. “This CE Mark issuance is a major accomplishment for Aurora Spine. TiNano® intervertebral implants […]
Zyga Receives 510(k) Clearance for SImmetry® Sacroiliac Joint Fusion System Updates
MINNETONKA, Minn., Aug. 13, 2015 /PRNewswire/ — Zyga Technology, Inc., a medical device company focused on the design, development and commercialization of minimally invasive devices to treat underserved conditions of the lumbar spine, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the SImmetry System using either […]
Oxford Performance Materials Receives FDA Clearance for Its SpineFab(R) VBR Implant System
SOUTH WINDSOR, Conn., July 23, 2015 (GLOBE NEWSWIRE) — Oxford Performance Materials, Inc. (OPM), a leading advanced materials and additive manufacturing (3D printing) company, today announced that it has received 510(k) clearance from the FDA for its first-in-kind SpineFab® VBR implant system.OPM’s SpineFab system is the first and only FDA cleared 3D printed load-bearing polymer […]
Cutting Edge Spine Receives FDA 510(k) Clearance for EVOS System: Lumbar Interbody Technology Includes Proprietary Implant Manufactured with PEEK-OPTIMA HA Enhanced
Waxhaw, NC (PRWEB) July 15, 2015–Cutting Edge Spine (http://www.cuttingedgespine.com), a technology-driven spine company focused on the development and distribution of highly differentiated spinal technologies, announced today that the US Food and Drug Administration has cleared the “EVOS system”. This groundbreaking system offers an extensive array of interbody implants manufactured in PEEK-OPTIMA NATURAL and the novel […]
FDA Clearance for joimax EndoLIF On-Cage: 3D-Printed Fusion Implant
IRVINE, Calif.–(BUSINESS WIRE)–The German company joimax®, developer of technologies and training methods for minimally invasive endoscopic spinal surgery, today announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Endoscopic Lumbar Interbody Fusion, or EndoLIF® On-Cage implant. The EndoLIF implant allows surgeons to utilize an inter-muscular approach, similar to […]
SpineGuard obtains regulatory clearance to sell PediGuard® in the world’s second-largest spine market: China
PARIS and SAN FRANCISCO, June 30, 2015 – SpineGuard (FR0011464452 – ALSGD) announced today that it has received regulatory clearance to market its Classic PediGuard® products in China.“This regulatory clearance is the result of a diligent collaborative process with General Care International (GCI),” said Pierre Jérôme, Co-founder and Chief Executive Officer of SpineGuard. “It is […]
Aesculap Receives FDA Approval for the activL® Artificial Disc for One-Level Lumbar Use
CENTER VALLEY, PA–(Marketwired – June 15, 2015) – Aesculap Implant Systems, LLC (Aesculap), a privately held medical device company, announced today that it has received a letter of approval from the U.S. Food and Drug Administration (FDA) allowing the commercial sale of the activL® Artificial Disc, for the treatment of one-level lumbar degenerative disc disease. […]
OrthoPediatrics Receives FDA Clearance for ResponseTM Spine System
Warsaw, Indiana, June 1, 2015 – OrthoPediatrics Corp. announced it has received 510(k) clearance from the U.S. Food and Drug Administration to market the ResponseTM Spine System. This system is intended for posterior, non-cervical fixation (pedicle screw fixation T1-S2/ilium and hook fixationT1-L5) in pediatric patients is indicated as an adjunct to fusion to treat Adolescent […]
G Surgical Announces FDA Clearance of their PEEK Cervical Spacer
Boulder, CO (May 26, 2015) –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 PEEK Cervical Spacer. The PEEK Cervical Spacer adds to the company’s portfolio and compliments the T-Lok Anterior Cervical System which […]
SpineCraft Announces FDA Approval of ASTRA Spine System for Deformity Correction and Complex Spine Procedures
May 19, 2015 – SpineCraft, LLC, a privately-held US medical device company, recently announced that it has received regulatory clearance from the U.S. Food and Drug Administration (FDA) to market its ASTRA Spine System – a comprehensive posterior spinal fixation system.The ASTRA Spine System is SpineCraft’s next generation deformity correction technology, designed by industry leading […]
VertiFlex®, Inc. Announces FDA PMA Approval for the Superion® Interspinous Spacer
SAN CLEMENTE, Calif.–(BUSINESS WIRE)–VertiFlex®, Inc., a leading innovator of advanced minimally invasive interventions for spinal stenosis, announced today that the U.S. Food and Drug Administration (FDA) has issued a PMA Approval Order for the company’s Superion® Interspinous Spacer System, clearing the way for commercialization in the United States. The Approval Order follows a February FDA […]
LinkSPINE Announces FDA (510)k Clearance of FacetLINK Fixation Platform
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 […]
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 […]
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 […]
Coflex Interlaminar
The coflex Interlaminar Technology is an Interlaminar Stabilization™ device indicated for use in one or two level lumbar stenosis from L1-L5 in skeletally mature patients with at least moderate impairment in function, who experience relief in flexion from their symptoms of leg/buttocks/groin pain, with or without back pain, and who have undergone at least 6 […]
DIAM
The DIAM (Device for Intervertebral Assisted Motion) Spinal Stabilization System provides flexible support of the lumbar spine while treating spinal degeneration. DIAM VIDEO ANIMATION DIAM-Medtronic.pdf Benefits: Provides an alternative to spinal fusion Fits between the interspinous processes and functions as a shock absorber that reduces loads on the surrounding vertebrae Only requires a small incision […]
SP-Fix
SP-Fix is a spinous process fixation device that is designed to provide structural stability, indirect decompression and immobilization of the spinous processes of adjacent vertebrae. SP-Fix VIDEO ANIMATION SP-Fix® is implanted using a minimally invasive approach and preserves the supraspinous ligament. SP-Fix® offers surgeons an easy-to-use system that helps preserve patient anatomy. SP-Fix® is not […]
Wallis
Wallis The Wallis Stabilization System, treats the pain due to degenerative instability, preserves mobility, anatomy and stability while being fully reversible, therefore leaving all subsequent options open. Benefits: Preserve Anatomy, Keep Options Open:Resulting in the preservation of anatomy, Wallis System keeps all options open in terms of potential future operations for low back disorders. Design […]
X-STOP
X-STOP The X-Stop® Spacer is an interspinous process device designed to treat the symptoms of lumbar spinal stenosis (LSS), a sometimes painful condition caused by narrowing of the spinal canal. The X-Stop Spacer is an implant designed to keep the space between your spinous processes open, so that when you stand upright, the nerves in […]
ZIP ULTRA™
The ZIP ULTRA™ MIS Interspinous Fusion Systemis a minimally invasive spinal fixation device for spinal fusion and was developed as an alternative to pedicle screw fixation. The ZIP ULTRA is designed for stabilization during T1-S1 thoracolumbar fusion procedures specifically for the treatment of degenerative disc disease, Spondylolisthesis, spinal tumors, and trauma. The ZIP ULTRA has a unique, […]
ZIP™ – MIS
The Aurora Spine ZIP™ MIS Interspinous Fusion System is a bilateral locking plate system which attaches to the posterior non-cervical spine at the spinous processes using Aurora Spine’s one-step, proprietary ZIP-LOCK™ mechanism. The implants have only two components (left & right) to assemble with a central chamber for receiving bone graft. The devices are available […]
K2M Receives 510(k) Clearance & CE Mark for MESA Hooks Used in Complex Spine Procedures
LEESBURG, Va., Sept. 2, 2014 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (Nasdaq:KTWO) (the “Company” or “K2M”), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to […]
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 […]