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 […]
FDA
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 […]
MEDICREA’s K-JAWS® Obtains FDA Approval for Its Marketing in the United States
LYON, France–(BUSINESS WIRE)–The MEDICREA Group: (Paris:ALMED) (FR0004178572-ALMED), which specializes in the development of innovative surgical technologies for the treatment of spinal pathologies and is listed on Alternext – Paris, announces that the FDA has approved the K-JAWS® Cervical Compression Staple for all cervical fixation indications carried out with interbody cages. MEDICREA has just obtained FDA […]
Medtronic Receives FDA Approval for PRESTIGE(R) LP Cervical Disc System
MEMPHIS, TENN. – July 28, 2014 – Medtronic, Inc. MDT -0.22% announces that it has received approval from the U.S. Food and Drug Administration (FDA) to market the PRESTIGE(R) LP Cervical Disc System for the treatment of single-level cervical disc disease (radiculopathy and/or myelopathy).The PRESTIGE(R) LP Cervical Disc is the third clinically proven artificial cervical […]
Expanding Orthopedics Inc. has obtained FDA Clearance for its FLXfit™, the world’s first 3D expandable interbody cage
OR AKIVA, Israel, July 21, 2014 /PRNewswire/ — Expanding Orthopedics Inc. (EOI), a privately held medical device company focused on developing and commercializing innovative expandable devices for spine surgeries, is excited to announce that its FLXfit™, the world’s first 3D expandable interbody cage, is cleared for commercialization in the US. Ofer Bokobza, CEO of Expanding […]
Titan Spine Receives FDA Clearance to Launch Endoskeleton® TL Device for Lateral Spinal Fusion
MEQUON, WIS. — Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to commercially release its Endoskeleton® TL system, a spinal fusion system utilizing a lateral approach. The Endoskeleton® TL represents the first […]
AccelSPINE Receives FDA Clearance on Picasso II
Dallas, TX / myprgenie.com / ACCESSWIRE / May 5, 2014 / AccelSPINE received FDA clearance on its Picasso II system in April. The system is designed to enhance the spinal implant experience for surgeons and patients.“Picasso II is the next generation of minimally invasive spine systems. It incorporates an easy-to-use, double-lead thread and self-tapping screw […]
TransCorp Spine Announces the U.S. Patent Issuance for a Cervical Locking Plate
Byron Center, Michigan – May 1, 2014 – TransCorp Spine, Inc., a privately-held medical device company focused on developing and commercializing innovative, minimally-invasive spine products and procedures announces that the U.S. Patent and Trademark Office issued Patent No. 8,709,054 for a locking plate used in anterior cervical fusion procedures. “This patent issuance recognizes our further […]
Medical device firm Baxano receives FDA clearance on surgical screw
Apr 10, 2014 (J. deBruyn-Triangle Business Journal)–Raleigh medical device company BaxanoSurgical, Inc. received clearance for its Avance MIS Pedicle Screw System, meaning it may now work towards a commercial launch of the product. Receiving clearance from the U.S. Food and Drug Administration is sort of the regulatory finish line for medical device companies like Baxano (Nasdaq:BAXS). […]
VertiFlex®, Inc. Announces Submission of Final PMA Module to the FDA, for the Superion® Interspinous Spacer System
SAN CLEMENTE, Calif.–(BUSINESS WIRE)–VertiFlex®, Inc., a leading innovator of advanced minimally invasive spinal surgery technologies, announces submission of the final module of the pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) to support approval for the Superion® Interspinous Spacer System. The final module covers the clinical results from the Superion IDE […]
EVONIK PEEK medical implants receive CE mark
Two medical implant cage systems made from PEEK supplied by Evonik Industries (Darmstadt / Germany; www.evonik.com) have received CE mark certification. Evonik says it supported the manufacturer, Tria Spine (Ankara / Turkey;www.triaspine.com), in obtaining the certificate with biocompatibility studies and technical documentation on its “Vestakeep” PEEK.“In cooperation with Evonik, we made it possible to replace […]
EVONIK PEEK medical implants receive CE mark
Two medical implant cage systems made from PEEK supplied by Evonik Industries (Darmstadt / Germany; www.evonik.com) have received CE mark certification. Evonik says it supported the manufacturer, Tria Spine (Ankara / Turkey;www.triaspine.com), in obtaining the certificate with biocompatibility studies and technical documentation on its “Vestakeep” PEEK.“In cooperation with Evonik, we made it possible to replace […]
Interventional Spine gets US FDA nod for additional sizes of Opticage Expandable Interbody Fusion Device
Interventional Spine, Inc. has received the US FDA clearance for eleven (11) additional sizes of the Opticage Expandable Interbody Fusion Device. The new sizes will allow surgeons to match an Expandable Opticage to more than 80 per cent of their patients requiring Lumbar Fusion surgery.The Opticage Expandable Interbody Fusion Device features a continuously adjustable height […]
Kiva® VCF Treatment System Receives FDA Clearance For Vertebral Compression Fractures
SANTA CLARA, Calif., Jan. 28, 2014 /PRNewswire/ — The Kiva® VCF Treatment System by Benvenue Medical, Inc. received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the reduction and treatment of spinal fractures. The Kiva System is a novel implant-based solution for vertebral augmentation and a departure from balloon kyphoplasty (BKP), making […]
Panel Agrees Spinal Sphere Devices Need Premarket Approval
(Medscape.com)–Given the lack of information on their effectiveness and the unreasonable risks for illness or injury, spinal sphere devices should be regulated as Class 3 devices that require premarket approval (PMA), according to members of the Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee to the Food and Drug Administration (FDA).The panel, […]
Aurora Spine Receives FDA 510(K) Clearance For ZIP(TM) MIS Interspinous Fusion System
CARLSBAD, California — (Marketwired) — 12/03/13 — Aurora Spine Corporation (TSX VENTURE: ASG) announced today that it has received U.S. Food and Drug Administration (“FDA”) 510(k) clearance for the company’s ZIP™ Minimally Invasive Interspinous Fusion System (the “ZIP”). Providing surgeons and patients with next generation technology, the ZIP is a minimally invasive spinal fixation device […]
Intelligent Implant Systems Receives US Approval for Torque-Less Cervical-Thoracic Spinal System
Intelligent Implant Systems (Charlotte, NC) has received FDA 510(k) clearance for the innovative Marauder cervical-thoracic spinal system. The Marauder has a unique locking mechanims that has no set screws and requires no torque. This enables easier rod reduction as the screw remains in place where positioned, helping to minimize implantation steps. The screws in this […]
FBC Device Receives EU Approval for an Innovative Spinal Implant
The innovative Danish medical device company, FBC Device, has received CE mark for its first spinal fusion implant, the Statur®-L, and ISO certification demonstrating the company’s adherence to the highest quality standards. With these accomplishments, the company can now introduce its pioneering spinal fusion device to the European and Canadian markets.“We are very pleased to […]
FDA Clears Innovative Spinal Fusion Device
MIAMI, Oct. 2013 /PRNewswire/ — Surgeons treating patients with degenerative disc disease may now use a new stand-alone intervertebral body fusion device recently cleared by the Food and Drug Administration. Manufactured by Binder Biomedical Inc., the device presents a complete anterior lumbar fixation system with a simple, one-step locking mechanism.Called LOGIC™, the system is designed […]
Ortho Kinematics Receives FDA 510(k) Clearance to expand into Cervical Spine
AUSTIN, Texas – August 15, 2013 — Ortho Kinematics‚ Inc. (OKI), a privately held healthcare diagnostic company focused on spine imaging informatics, announced receiving 510(k) clearance from the U.S. Food and Drug Administration to expand the VMA (Vertebral Motion Analysis) system beyond the lumbar spine, so that the system can be available for cervical spine […]
LDR Receives FDA Approval for the Mobi-C Cervical Disc for One-Level Use
AUSTIN, TEXAS — LDR, a privately held medical device company offering exclusive spinal implant technologies for both non-fusion and fusion applications, today announced that it has received a letter of approval from the U.S. Food and Drug Administration (FDA) allowing the commercial sale and distribution of the Mobi-C® Cervical Disc (Mobi-C), for one-level indications in […]