FDA

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 […]

NeuroStructures is excited and pleased to announce the FDA 510k approval of the Oculus™-SA Lumbar Cage System, which features our “Neuro-Lock” surface technology to enhance fusion. The Oculus™-SA allows the surgeon to use multiple integrated screw construct options for any surgeons’ preference. Along with a zero profile design and locking plate for secure visual confirmation, […]

OWINGS MILLS, Md., Sept. 10, 2020 /PRNewswire/ — IZI Medical Products, LLC (“IZI”), a leading manufacturer of interventional radiology devices, announces that it has received CE Mark approval in Europe for the KivaTM Vertebral Compression Fracture (VCF) Treatment System. Kiva is a unipedicular PEEK implant-based treatment solution for VCFs that has seen clinical and commercial success in the US. “We […]

Huntley, IL, August 5 , 2020 –Life Spine, a 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 PLATEAU-A Ti Anterior Lumbar Spacer System. “With the increased usage of […]

NeuroStructures is excited and pleased to announce the FDA 510k approval of the Transept™ Cervical Plating System which features the ability to achieve extreme screw angulation (up to 38°) and extremely short plates (10mm). The plate has an ultra-thin profile and comes with a wide spectrum of fixed, variable, self-tapping, and self-drilling screws. Also included, […]

ALTSTAETTEN, Switzerland, June 18, 2020 /PRNewswire/ — icotec ag announces that the KONG®-TL and the KONG®-C vertebral body replacement systems with the unique Titaniumcoating (Ti-iT®) receive FDA 510(k) clearance in the United States and CE approval in Europe .”This is exciting news for icotec ag and our team as it allows us to expand our portfolio in multiple countries simultaneously, to include implants […]

ATLANTA, June 1, 2020 /PRNewswire/ — Meditech Spine has received FDA 510(k) clearance to market the CURE™ Opel-L (S) system, a new lumbar plate option which expands upon the previously cleared CURE™ LP Plate System and compliments its Talos®-A (HA) Interbody system. With this approval, Meditech will now offer an Interbody/Plate assembly for the anterior lumbar spine. By […]

SAN RAMON, Calif., June 20, 2018 /PRNewswire/ — Tenon Medical, Inc., a manufacturer of minimally invasive instruments and implants for sacroiliac joint fusion surgery, today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the Catamaran™ Sacroiliac Joint Fixation System (CAT SIJ Fixation System) specifically indicated for sacroiliac joint fusion […]

NEW YORK, June 7, 2018 /PRNewswire/ — Centinel Spine, LLC is pleased to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its FLX™ Platform of Integrated Interbody™ and non-integrated interbody fusion devices.  Centinel Spine is the largest privately-held spine company, focused on anterior column reconstruction. FLX devices are 3D-printed, […]

CARLSBAD, CA – June 4, 2018 – Astura Medical, a high growth, innovative spine technology company, today announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ALTA ACDF Interbody Spacers and HALF DOME Lumbar Interbody Spacers in PEEK-OPTIMAä HA Enhanced from Invibio Biomaterial Solutions. Combining the clinically proven […]

ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., announces FDA clearance of its Rampart One™ Standard ALIF device allowing it to be used with or without supplemental fixation. “Following the success of our beta launch, this stand-alone clearance will provide additional momentum as we prepare for the full market release of the Rampart One ALIF Interbody Fusion System,” […]

WAYNE, Pa., June 4, 2018 /PRNewswire/ — Camber Spine today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its ENZA™-A Titanium Anterior Lumbar Interbody Fusion (ALIF) system, a unique, minimally invasive interbody fusion device providing integrated fixation. Daniel Pontecorvo, CEO, said, “ENZA™-A leverages two of Camber […]

(MDDIONLINE.COM) –Although FDA doesn’t have to follow the recommendation of its advisory committees, a negative panel vote is never a good sign for a company hoping to bring a new device to the market. Intrinsic Therapeutic learned the hard way Tuesday that it’s usually best if clinical trials follow the protocol that was initially communicated to […]

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 […]