Astura Medical Receives FDA 510(k) Clearance For OLYMPIC MIS Posspinal cord implant for paralysisterior Spinal Fixation System

CARLSBAD, CA – November 26, 2018 – 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 Olympic Minimally Invasive Surgery (MIS) Posterior Spinal Fixation System. The Olympic MIS system delivers a new level of intraoperative flexibility and efficiency …

OrthoPediatrics Corp. Receives FDA 510(k) Clearance for Small Stature Scoliosis System with 2hip surgery6th Surgical System

WARSAW, Ind., Oct. 19, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ: KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new RESPONSE 4.5/5.0mm System for treating smaller stature younger patients with complex scoliosis.  The system represents the …

SpineVision® Receives FDAinnovations in healthcare technology Clearance and CE Mark for Next-Gen Titanium 3D-Printed HEXANIUM TLIF Cage

implants new york September 17, 2018 ANTONY, France–(BUSINESS WIRE)–SpineVision announced today that it has received FDA clearance and CE mark for its next-generation titanium 3D laser-printed HEXANIUM TLIF (Transforaminal Lumbar Interbody Fusion) cage for back surgery. SpineVision will introduce its new product to spine surgeons at “EuroSpine 201stryker medical8”(Booth #24C) in Barcelona, Spain (Sept. 19-21), and “NASS 2018” (Booth #1311) in Los Angeles (Sept. 26-29). …

SpineVision® Receives CE Mark for Next-Gen P.neck disc surgeryL.U.S.® Deformity-Correction Spinal System

ANTONY, France–(BUSINESS WIRE)–SpineVision announced today that it has received CE mark for its next-generation Pivot Link Universal Systemspinal cord stimulator (P.L.U.S.) spine deformity-correction system. SpineVision will introduce the next-generation P.L.U.S. to spine surgeons at “EuroSpine 2018” (Booth #24C) in Barcelona, Spain (Sept. 19-21), and “NASS 2018” (Booth #1311) in Los Angeles (Sept. 26-29). Deformity of the spine includes any abnormality of the formation, alignment, or shape of …

Meditech Spine Receives FDA Clearance for its Curespinal surgery recovery™ Opel-C Plating System

ATLANTA, Sept. 18, 2018 /PRNewswire/ — Meditech Spine has received FDA 510(k) clearance to market the Cure™ Opel-C Plate System, an add-on technology to its already cleared CURE™ ACP System and Talos®-C (HA) Interbody Systems. With this approval, Meditech will now offer two additional CURE™ ACP plating options with its Talos® line of cervical interbodies made with the …

Medicrea Receives World’s First and Onllaparoscopic disc surgeryy FDA-Clearance to Market Patient-Specific Cages

May 31, 2018 LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea® Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered spinal device design with UNiD ASI™ (Adaptive Spine Intelligence) technology, announced today that it has obtained the first and only 510(k) clearance from the U.S. Food & Drug Administration (FDA) …

Astura Medical Receives FDA bulging disc pain510(k) Clearance For Cervical and Lumbar HA PEEK Interbody Systems

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 strength and …

Xtant Medical Receives FDA 510(K) Clearance for InTice(TM)-C Porous Titanimicrodiscectomy spine surgeryum Cervical Interbody System

BELGRADE, MT / ACCESSWIRE / May 21, 2018 / Xtant Medical Holdings, Inc. (NYSE American: XTNT), a leader in the development of regenerative medicine products and medical devices, announces U.S. Food and Drug Administration (FDA) 510(k) clearance for InTice™-C Porous Titanium Cervical Interbody System. InTice-C is designed using OsteoSync Ti, a best-in-class, cost-effective, highspine conditionsly porous …

K2M Receivestenosis pains FDA Clearance for BACS® Patient-Specific Module

LEESBURG, Va., May 30, 2018 (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 U.S. Food and Drug Administration (FDA) 510(k) clearance for BACS® Patient-Specific devices. With the BACS Surgical Planner, surgeons can create pre-contoured rods, rails, …

Spineology Receives a Notice of Allowance for a New US Patent on its Duo™ Lumbar spinal cord stimulator implantInterbody Fusion Implant

March 05, 2018 ST. PAUL, Minn.–(BUSINESS WIRE)–Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application No. 15/476,911, “Mesh Spacer Hybrid.” The allowed claims include three independent device claims covering Spineology’s Duo implant, a …