TUTTLINGEN, GERMANY (PRWEB) JANUARY 16, 2018–Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative 3D printed titanium implants for spinal applications today announced the U.S. Food and Drug Administration (FDA) clearance of the expansion of the label of their EIT Cellular Titanium® Cervical Cage to be used in multiple contiguous […]
FDA
Why an FDA Panel Shot Down Intrinsic’s Spinal Implant?
(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 […]
SeaSpine Announces FDA 510(k) Clearance of OsteoBallast™ Demineralized Bone Matrix in Resorbable Mesh
CARLSBAD, Calif., Nov. 30, 2017 (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 United States Food and Drug Administration (FDA) for use of its OsteoBallast™ Demineralized Bone Matrix (DBM) in Resorbable […]
Atlas Spine Receives FDA Clearance for Ortus Expandable Posterior Lumbar Interbody System
PR Newswire11.01.17–Atlas Spine Inc., a high technology, spinal implant and instrumentation company based in Jupiter, Fla., has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Ortus Expandable Posterior Lumbar Interbody System. The device is designed to be delivered using either minimally invasive or open surgical approach. The Ortus PL is clearly differentiated […]
Pinnacle Spine Group Files Application with FDA for 510(k) Clearance to Market their InFill® Lateral Fusion System with PEEK-OPTIMA™ HA Enhanced Polymer
DALLAS & THORNTON CLEVELEYS, UK (PRWEB) OCTOBER 31, 2017–Pinnacle Spine Group, LLC, the pioneer of in situ graft delivery in spinal fusion, today announced it has filed an application with the Food and Drug Administration (FDA) seeking 510(k) clearance to market its lateral InFill® Lumbar Fusion Systems with PEEK-OPTIMA HA Enhanced polymer from Invibio Biomaterial […]
NuVasive Receives Expanded FDA 510(k) Clearance For TLX Interbody System Used In TLIF Procedures
SAN DIEGO, Oct. 16, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced an expanded U.S. Food and Drug Administration (FDA) 510(k) clearance of the Company’s TLX interbody system, used in the leading spinal fusion surgery. New clearance introduces an […]
NuVasive Receives Expanded FDA 510(k) Clearance For Innovative Magnetic Limb Lengthening Technology
SAN DIEGO, Oct. 12, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced that it has received expanded 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company’s PRECICE® system from NuVasive Specialized Orthopedics™ (NSO) with expanded […]
ChoiceSpine™ Granted FDA Clearance for 3D Printed Vertebral Body Replacement Device
KNOXVILLE, TN (PRWEB) OCTOBER 04, 2017-ChoiceSpine LP, a privately-held spinal device manufacturer based in Knoxville, TN, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market HAWKEYE Ti, a 3D Printed Titanium Vertebral Body Replacement (VBR) device. “Additive manufacturing techniques create intricate three-dimensional implants, layer by layer, allowing a […]
Nexxt Spine Announces FDA Clearance for the NEXXT MATRIXX™ System
NOBLESVILLE, Ind.–(BUSINESS WIRE)–Nexxt Spine, LLC, a medical device company focused on designing, manufacturing, and distributing innovative spinal solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the NEXXT MATRIXX™ System. The NEXXT MATRIXX™ System of 3D printed porous titanium leverages Nexxt generation technology to create […]
K2M Receives FDA Clearance for Next-Generation YUKON™ OCT Spinal System
LEESBURG, Va., Sept. 29, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its YUKON™ OCT Spinal System. YUKON OCT offers […]
EOI Announces FDA Clearance for the FLXfit15, the Only 3D Articulated Expandable Cage With 15 degrees of Lordosis Correction
OR AKIVA, Israel, September 28, 2017 /PRNewswire/ — Expanding Orthopedics Inc. (EOI), a privately-held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, today announced FDA 510(k) clearance for the FLXfit™15, enhancing the already successful FLXfit™ 3D Expandable Cage System. The FLXfit™15 will expand the surgeon’s flexibility and capability by offering a family […]
NeuroStructures Receives 510k Clearance for Trifore™ Anterior Cervical Plating System
NeuroStructures received 510(K) clearance from the U.S. FDA to market the Trifore™ Anterior Cervical Plating System. This new technology cervical plate system incorporates more of NeuroStructures, Inc. patented technologies allowing for a one-step locking mechanism with visual and tactile lock verification and screw height variances. About NeuroStructures NeuroStructures is an employee-owned and operated medical device […]
Xtant Medical Receives 510k Clearance for Expanded Indications of Irix-A
BELGRADE, Mont., Sept. 12, 2017 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced that the U.S. Food and Drug Administration (FDA) has cleared product line extensions for the Irix-A interbody spacer. The clearance provides for the addition of three additional […]
Implanet Announces Clearance of the New JAZZ™ Passer
BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News: IMPLANET (Euronext Growth: ALIMP, FR0010458729, PEA-PME eligible) (Paris:IMPL) (OTCQX:IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today announces that it has received FDA clearance to market the new JAZZ™ Passer. JAZZ™ Passer comprises new passer instruments and a variation of the JAZZ™ Band braid, the JAZZ™ Passer […]
Spinal Resources, Inc.®’s Swedge Pedicle Screw System Receives FDA 510(k) Clearance
FT. LAUDERDALE, Fla., Sept. 7, 2017 /PRNewswire/ — Spinal Resources, Inc.® (SRI) announced that it has received FDA 510(k) clearance for its Swedge™ Pedicle Screw System. This unique system offers multiple benefits, including CoCr and Titanium tulips; double lead and Cortical Cancellous Threads; Polyaxial, Monoaxial, Reduction, and Iliac screws; and MIS (minimally invasive spinal surgery) options. Currently, the Swedge system […]
Globus Medical Announces FDA 510(k) Clearance for Excelsius GPS™
AUDUBON, Pa., Aug. 17, 2017 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced that the Excelsius GPS™, a revolutionary robotic guidance and navigation system, has been 510(k) cleared by the U.S. Food and Drug Administration. This platform technology supports minimally invasive and open orthopedic and neurosurgical procedures, with screw […]
Stryker’s Spine Division Receives FDA Clearance for Serrato Pedicle Screw
ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced that its Serrato™ Pedicle Screw, intended for use in the non-cervical spine as part of the company’s successful Xia® 3 Spinal System, has received 510(k) clearance from the U.S. Food and Drug Administration. Serrato Pedicle Screws feature enhanced serrated cutting flutes, a unique dual-thread pattern with an increased […]
Camber Spine Technologies Announces FDA Clearance And National Launch Of SPIRA™ Open Matrix ALIF
WAYNE, Pa., Aug. 15, 2017 /PRNewswire/ — Camber Spine Technologies announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its SPIRA™ Open Matrix ALIF device, a unique, interbody fusion implant consisting of spiral support arches and Surface by Design™ technology. This clearance marks Camber’s tenth line […]
Renovis® Surgical Receives FDA Clearance for 3D-Printed Posterior Lumbar Interbody Fusion Systems
REDLANDS, Calif., Aug. 11, 2017 /PRNewswire/ — Renovis Surgical Technologies, Inc. announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market posterior lumbar Tesera® porous titanium interbody fusion systems. These systems feature implants for direct posterior (PLIF) or transforaminal (TLIF) approaches in both straight and curved options. Multiple heights, widths […]
Xtant Medical Receives FDA Clearance for Calix-C Cervical Interbody Line Extension and Expanded Indications
BELGRADE, Mont., Aug. 09, 2017 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced that the U.S. Food and Drug Administration (FDA) has cleared product line extensions for the Calix-C family of cervical interbody cages. The clearance provides for the addition […]
EIT 3D printed titanium cage portfolio receives FDA approval
ATLANTA, GA (PRWEB) JULY 18, 2017–Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application by utilizing additive manufacturing, announces that it has received full approval from the FDA to commercialize its spinal interbody product offerings for ALIF, TLIF, PLIF and Cervical procedures. EIT Cellular Titanium® is […]
K2M Receives FDA Clearance & CE Mark for NILE® Proximal Fixation Spinal System
LEESBURG, Va., July 06, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and a CE Mark for its NILE® Proximal Fixation […]
K2M First-to-Market with 3D-Printed Corpectomy Cage System Following FDA Clearance of CAPRI™ Small 3D Static Featuring Lamellar 3D Titanium Technology™
LEESBURG, Va., June 28, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced that its CAPRI™ Small 3D Static Corpectomy Cage System has received 510(k) clearance from the U.S. Food & Drug […]
Spineology® Announces FDA Clearance of Rampart One™ Anterior Lumbar Interbody Fusion System
ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology, Inc. the innovator in anatomy-conserving surgery™, is excited to announce FDA clearance of the Rampart One Anterior Lumbar Interbody Fusion System. Rampart One is designed to minimize the exposure and vascular retraction requirements associated with traditional anterior spinal fusion procedures. The system includes both standard and oblique interbody device footprints each […]
Life Spine Announces 510(k) Clearance of the CRANIAL FUSION System with SOLSTICE® Screws for Cervical Spine Indications
HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, is pleased to announce the FDA 510(k) clearance of the CRANIAL FUSION System. This clearance expands the indications for utilizing SOLSTICE Polyaxial Screws into the cervical spine. “With the clearance of the Cranial […]
Providence Medical Technology Receives New FDA 510(k) Clearances and Bolsters Executive Management Team
WALNUT CREEK, Calif., Mar 29, 2017 /PRNewswire/ — Providence Medical Technology, Inc., an innovator in tissue-sparing, cervical-fusion technology, announced the addition of two industry veterans to the commercial leadership team. Scott Lynch has joined the company to lead Global Marketing, and Michael Scott is assuming International leadership. Together, Mr. Lynch and Mr. Scott have over 40 […]
NuVasive Receives First-Ever FDA Clearance For Cervical Interbody Implant System Used In More Than Two Levels
SAN DIEGO, March 29, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the CoRoent® Small Interbody™ System indicated for intervertebral body fusion at multiple contiguous levels in the cervical spine. This […]