FDA

February 28, 2022– SpineUp a privately held medical technology company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its brand new cervical cage in Peek Optima HA-Enhanced, Romero.They offer to the surgeons 4 types of cervical cages: Lordotic with screw (self-tapping or self-drilling), anatomic with screw, anatomic and lordotic without […]

Tallahassee, FL – February 1, 2021—VySpine, VySpine, a spine innovation leader using differentiated materials and designs, announced today that it has received 510(k) clearance from the FDA for the its ClariVy Cervical IBF System which is designed for use in anterior cervical discectomy with fusion (ACDF) procedures.  The ClariVy Cervical IBF System features cervical interbody fusion devices made […]

RA’ANANA, Israel – January 18, 2022 – VUZE Medical, a privately held medical technology company aimed at transforming image guidance and verification in minimally invasive spine surgeries, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its VUZEÔ System. Using proprietary image processing, the VUZE System is a software-only solution that overlays a graphical […]

SAN DIEGO, April 6, 2021 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the NuVasive Simplify® Cervical Artificial Disc (Simplify Disc) received approval from the U.S. Food and Drug Administration (FDA) for two-level cervical total disc replacement (cTDR). “This approval is an incredible […]

NORWALK, Conn. – March31, 2021 – Premia Spine, a medical technology company aiming to change the way debilitating chronic leg and back pain is treated, today announced that its TOPS facet arthroplasty system won Breakthrough Device Designation from the U.S. Food & Drug Administration. TOPS is the first and only facet joint replacement system for […]

SCOTTSDALE, Ariz., March 30, 2021 /PRNewswire/ — NGMedical, a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application, announces FDA clearance for its anatomically shaped cervical interbody BEE® HA, made of the innovative PEEK-OPTIMA™ HA Enhanced from Invibio Biomaterial Solutions, a global leader in high-performance biomaterial solutions.  BEE® HA was developed to optimize fusion while maintaining […]

CARLSBAD, Calif., March 25, 2021 (GLOBE NEWSWIRE) — Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative medical devices that improve spinal surgery outcomes, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its proprietary APOLLO Anterior Cervical Plate (ACP) […]

Huntley, IL, March 18th, 2021 –Life Spine, a leading medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the PROLIFT Wedge Expandable Spacer System. The PROLIFT Wedge Expandable Interbody Spacer […]

DALLAS, March 17, 2021 /PRNewswire/ — 4WEB Medical, an orthopedic device company focused on developing innovative implants with an Advanced Structural Design utilizing its proprietary Truss Implant Technology™, announced today that the company has received 510(k) clearance from the U.S. Food & Drug Administration to market its Lumbar Plating Solution (LSTS-PS). The new plating solution consists of a […]

BOULDER, Colo., Feb. 25, 2021 /PRNewswire/ — Fusion Robotics LLC, a spinal robotics and navigation company today announced receiving 510(k) clearance to market their 3D imaging compatible navigation and robotic targeting system for spine surgery in the U.S. market. The Fusion Robotics System addresses the key limitations of current spinal navigation and robotics systems by offering greater […]

Chicago, February 22, 2021—Brainlab announced today that the company has reached two major milestones with the FDA clearance for both Loop-X® Mobile Imaging Robot and Cirq®, a robotic surgical system. Following on CE mark approvals last summer, the FDA clearance paves the way for Brainlab to now enter the US markets with the Cirq robotic […]

February 4, 2021 – Parsippany, NJ – Precision Spine, Inc., a medical device company dedicated to Madein-the-USA manufacturing, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Dakota ACDF™ Standalone System in the treatment of degenerative disc disease (DDD). The Dakota ACDF system features a titanium […]

SCOTTSDALE, Ariz., Feb. 3, 2021 /PRNewswire/ — NGMedical, a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application, announces FDA clearance for its purely additively manufactured titanium cervical BEE® cage. The BEE® cage is designed to challenge the limits of additive manufacturing. The purposefully designed honeycomb endplate design reduces the risk of subsidence while allowing […]

Carlsbad, CA – January 26, 2021 –Spinal Elements, a spine technology company, today announced the FDA clearance of the Lucent® XP-Curved Expandable Interbody Device. Lucent XP-Curved is the third platform in the Lucent XP family of expandable devices and the fifth expandable device within Spinal Elements’ MIS Ultra™ suite of products and procedures. The device and […]

BURNSVILLE, Minn., Jan. 26, 2021 /PRNewswire/ — Inspired Spine has announced the Trident SI Joint Screw System, manufactured by Advanced Research Medical (ARM), has secured FDA 510(k) marketing clearance. “We continue to raise the standard of care for back pain treatment as this SI Joint fusion technique represents another Inspired Spine breakthrough for surgeons and patients alike,” stated […]

KNOXVILLE, Tenn.–(BUSINESS WIRE)–ChoiceSpine LLC, a privately held spinal device manufacturer based in Knoxville, TN, announced today that the Food and Drug Administration (FDA) has provided additional 510(k) clearance to the Tiger Shark Cervical Spacer System. Tiger Shark C is comprised of titanium alloy and constructed into an anatomical form, complementing the shape of vertebral bodies. […]

DUBLIN, Dec. 16, 2020 /PRNewswire/ — Medtronic plc (NYSE: MDT) announced that the U.S. Food and Drug Administration (FDA) has cleared the use of navigated interbody and Midas Rex™ high speed drills with the Mazor™ Robotic Guidance System earlier than originally anticipated. The Mazor™ platform now provides surgeons with unprecedented procedural integration by seamlessly combining the power of Midas Rex™ drills […]

CARLSBAD, Calif., Dec. 15, 2020 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its NanoMetalene® surface technology with amended indications. NanoMetalene describes […]

ALTSTAETTEN, Switzerland, Nov. 10, 2020 /PRNewswire/ — icotec ag, the leading medical device manufacture of Carbon/PEEK spinal implants, announces the U.S. Food and Drug Administration (FDA) 510(k) clearance to market the VADER® Pedicle – System for use with bone cement for augmentation or without. The VADER® Pedicle System is intended to restore the integrity of the spinal column even […]

SAN DIEGO, Nov. 4, 2020 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its thoracolumbar interbody portfolio to include the treatment of multi-level sagittal deformities of the […]

IRVING, TX – November 9, 2020 – Astura Medical, a high-growth, innovative spine technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Dolomite Stand-Alone Anterior Cervical Stabilization System. Expanding on the rapid adoption and recent success of the company’s other integrated plate and spacer technologies […]

Indius Medical Technologies, an Indo – US multinational Startup focused on the development of US FDA compliant global quality products for the treatment of spinal disorders has FDA clearance for the ACURA Thoracolumbar Posterior System. The ACURA System features the following implants: Paediatric Screw Head Profile with Adult Load Bearing Strength enables O.R. Efficiency Anti-Splay […]

San Antonio, Texas/ Thornton Cleveleys (UK), October 28, 2020 – Nvision Biomedical Technologies, a San Antonio-based medical device and implant manufacturer, has FDA clearance for the first osteotomy wedge system made from PEEK-OPTIMA HA Enhanced, a polymer from Invibio Biomaterial Solutions (‘Invibio’). The Trigon® Stand-Alone Osteotomy Wedge Fixation System has osteoconductive properties that promote multi-directional bone healing and […]

Bordeaux, Boston, October 19, 2020 – 5.45 pm CEST: IMPLANET (Euronext Growth: ALIMP, FR0013470168, eligible for PEA-PME equity savings plans), a medical technology company specializing in vertebral and knee-surgery implants, and SeaSpine Holdings Corporation (NASDAQ: SPNE) today announce the clearance of the Mariner Cap System in the United States, which combines SeaSpine’s Mariner® pedicle screw system with […]

Following the recent FDA approval to initiate a pivotal IDE clinical study for the BAGUERA® C artificial cervical disc at 1-level, Spineart is proud to announce that it has received approval from the FDA to initiate as well a pivotal IDE clinical study for BAGUERA® C at two contiguous levels.Both studies will be randomized controlled trials comparing the […]

SMAIO is delighted to share that our spinal fixation system KHEIRON® just received FDA-510(k) clearance.This big step for SMAIO will allow us to start commercializing our innovative solutions on the US market and will sustain our international development. KHEIRON is a Posterior thoraco-lumbar fixation system offering a full range of implants to adress the main […]