Regulatory

Exactech Expands Presence in Japan with Newly Approved Shoulder, Knee and Hip Replacement Systems
Recon Regulatory

Exactech Expands Presence in Japan with Newly Approved Shoulder, Knee and Hip Replacement Systems

June 22, 2017 GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, announced today that the company marked the first clinical use of recently approved shoulder, knee and hip replacement systems in Japan this quarter. […]

K2M First-to-Market with 3D-Printed Expandable Interbody System Following FDA Clearance of MOJAVE™ PL 3D
Regulatory Spine Top Stories

K2M First-to-Market with 3D-Printed Expandable Interbody System Following FDA Clearance of MOJAVE™ PL 3D

LEESBURG, Va., June 22, 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 MOJAVE™ PL 3D Expandable Interbody System has received 510(k) clearance from the U.S. […]

Implanet announces the commercial launch of the new JAZZ™ braid in Europe and the United States
Regulatory Top Stories

Implanet announces the commercial launch of the new JAZZ™ braid in Europe and the United States

June 22, 2017 BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News: IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext: IMPL, FR0010458729, PEA-PME eligible; OTCQX: IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today announces that it has obtained marketing clearance from the U.S. and European regulatory authorities to market its new JAZZ™ braid. The […]

Zyga Receives New Patent Allowances for SImmetry® Sacroiliac Joint Fusion System
Regulatory Spine Top Stories

Zyga Receives New Patent Allowances for SImmetry® Sacroiliac Joint Fusion System

MINNETONKA, Minn., June 21, 2017 /PRNewswire/ — Zyga Technology, Inc., a medical device company focused on the design, development and commercialization of minimally invasive devices to treat underserved conditions of the lumbar spine, today announced the issuance of a new US Patent representing continued advancement of the SImmetry Sacroiliac Joint Fusion […]

Kuros receives CE certification for Neuroseal®, a novel dural sealant
Biologics Regulatory Top Stories

Kuros receives CE certification for Neuroseal®, a novel dural sealant

Schlieren (Zurich), Switzerland, June 21, 2017 – Kuros Biosciences (SIX:KURN) announced today that it has received CE certification for its novel dural sealant, Neuroseal® . The CE certification allows for the commercialization of the product anywhere in the European Economic Area. As part of the supporting evidence, Neuroseal® has been […]

ConforMIS Announces FDA 510(k) Clearance for iTotal Hip System
Recon Regulatory Top Stories

ConforMIS Announces FDA 510(k) Clearance for iTotal Hip System

BILLERICA, Mass., June 20, 2017 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that offers knee replacement implants customized to fit each patient’s unique anatomy, today announced it has received FDA 510(k) clearance of the Company’s primary iTotal Hip replacement system. “Having treated over 50,000 patients with customized […]

Next Generation Lumbar Fusion Devices by Meditech Spine Aims to Improve Surgical Outcomes, Receives FDA Clearance
Regulatory Spine

Next Generation Lumbar Fusion Devices by Meditech Spine Aims to Improve Surgical Outcomes, Receives FDA Clearance

ATLANTA, June 19, 2017 /PRNewswire/ — Spine surgery offers a new lease on life for patients experiencing back pain and discomfort. With an estimated 450,000+ lumbar fusions performed each year in the United States, surgeons are familiar with Meditech Spine’s Talos® Lumbar Peek devices as essential components in the procedures […]

Medicrea Announces FDA Clearance and Initial Experience with PASS® TULIP Top-Loading Fixation
Regulatory Spine Top Stories

Medicrea Announces FDA Clearance and Initial Experience with PASS® TULIP Top-Loading Fixation

June 16, 2017 LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Alternext Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ ASI technology, announced today that it has received FDA 510(k) Clearance and performed first surgeries with PASS® TULIP top-loading […]

Medicrea Receives FDA Clearance for the UNiD™ HUB, a Data-Driven Digital Portal for Adaptive Spine Intelligence
Regulatory Spine Top Stories

Medicrea Receives FDA Clearance for the UNiD™ HUB, a Data-Driven Digital Portal for Adaptive Spine Intelligence

June 16, 2017 LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Alternext Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ ASI technology, announced today that it has received 510(k) Clearance from the Food & Drug Administration for UNiD™ HUB, […]

Zimmer Biomet Holdings Announces Resolution of FDA Warning Letter Related to Its Zhejiang, China Manufacturing Facility
Regulatory Top Stories

Zimmer Biomet Holdings Announces Resolution of FDA Warning Letter Related to Its Zhejiang, China Manufacturing Facility

WARSAW, Ind., June 13, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that the Warning Letter dated June 3, 2015 relating to its Zhejiang, China manufacturing facility […]

SI-BONE Wins FDA Clearance and Full U.S. Commercial Launch of the iFuse-3D Implant
Regulatory Spine

SI-BONE Wins FDA Clearance and Full U.S. Commercial Launch of the iFuse-3D Implant

SAN JOSE, Calif., June 13, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, today announced FDA clearance and full U.S. […]

Vertera Spine Receives New CMS ICD-10 Code for Radiolucent Porous Interbody Fusion Devices
Regulatory Spine Top Stories

Vertera Spine Receives New CMS ICD-10 Code for Radiolucent Porous Interbody Fusion Devices

ATLANTA, June 13, 2017 /PRNewswire/ — Vertera Spine, a developer of medical devices using advanced biomaterial technologies, today announced the U.S. Centers for Medicare & Medicaid Services (CMS) has issued a new ICD-10 code for a radiolucent porous interbody fusion device. The new classification will enable healthcare providers and payers to […]