fda clearance
-
Recon
Smith+Nephew’s PICO™ 7 and PICO 14 Negative Pressure Wound Therapy Systems are the first systems indicated to aid in reducing the incidence of both deep and superficial incisional surgical site infections and dehiscence
LONDON, Jan. 24, 2022 /PRNewswire/ — Smith+Nephew (LSE:SN,NYSE:SNN), the global medical technology business, is pleased to announce new indications for use for…
Read More » -
Regulatory
Spinal Simplicity Minuteman Lumbar Spinal Stenosis Indication for Use
Spinal Simplicity’s mission is to provide safe, minimally invasive solutions to treat complex spinal and orthopedic disorders. OVERLAND PARK, KAN.…
Read More » -
Biologics
Ortho Regenerative Technologies Announces U.S. IND Clinical Hold Lifted By The FDA & Clearance To Proceed With U.S. Clinical Trial
MONTREAL, Dec. 13, 2021 /PRNewswire/ – Ortho Regenerative Technologies Inc. (CSE: ORTH) (OTCQB: ORTIF) (“Ortho” or the “Company”), a clinical-stage orthobiologics company focused on the…
Read More » -
Regulatory
Eminent Spine’s Anterior Cervical Plate System Receives FDA Clearance for Enhanced Curvature and Low-Profile Locking Tab
Eminent Spine’s Anterior Cervical Plate System has received 510(K) clearance from the FDA to offer a modern, low-profile option to…
Read More » -
Regulatory
ChoiceSpine LLC Announces FDA Clearance of Triton™ SI Joint System
October 5, 2021 KNOXVILLE, Tenn.–(BUSINESS WIRE)–ChoiceSpine LLC, a privately-held spinal device manufacturer based in Knoxville, TN, announced today that it…
Read More » -
Spine
NGMedical GmbH Receives FDA Clearance for Its AM Titanium Lumbar Interbody BEE® PLIF
NGMedical announces the clearance of its third spinal implant this year. SCOTTSDALE, AZ, September 27, 2021 /OrthoSpineNews/ – NGMedical, a German…
Read More » -
Regulatory
joimax® Receives FDA Clearance to Market EndoLIF® Delta-Cage and DoubleWedge-Cage in the USA
September 7, 2021 KARLSRUHE, Germany–(BUSINESS WIRE)–German-based joimax®, the market leader in technologies and training methods for full-endoscopic and minimally invasive spinal…
Read More » -
Extremities
In2Bones Receives FDA Clearance for Pre-Surgery OrthoPlanify Patient-Specific Planning Software and 3D-Printed Cutting Guides for QUANTUM® Total Ankle System
Innovative Total Ankle System to be Showcased at Upcoming AAOS and AOFAS Annual Meetings September 1, 2021 MEMPHIS, Tenn.–(BUSINESS WIRE)–In2Bones Global,…
Read More » -
Extremities
The Orthopaedic Implant Company Launches FDA Cleared DRPx Wrist Fracture Plate
RENO, NV / ACCESSWIRE / August 4, 2021 / The Orthopaedic Implant Company today announced the FDA clearance and commercial launch of…
Read More » -
Recon
Vuzix Smart Glasses Expand AR Surgical Product Presence to Support Shoulder, Knee and Spine Surgeries
– NextAR surgical AR platform developed by Medacta International receives CE marking for knee, shoulder and spine applications. – NextAR…
Read More » -
Regulatory
Medtronic Gains FDA Clearance of UNiD™ Patient-Specific Rods for Use with CD Horizon™ Solera™ Voyager™ and Infinity™ OCT Spinal Systems
DUBLIN, June 3, 2021 /PRNewswire/ — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the U.S. Food and Drug…
Read More » -
Regulatory
ChoiceSpine™ Announces FDA Clearance and Clinical Use of Blackhawk™ Ti Cervical Spacer System
May 25, 2021 KNOXVILLE, Tenn.–(BUSINESS WIRE)–ChoiceSpine LLC, a privately held spinal device manufacturer based in Knoxville, TN, announced today that…
Read More » -
Recon
THINK Surgical and Ortho Development Announce FDA Clearance for Use of Balanced Knee System and BKS TriMax Implants with TSolution One Total Knee Application Active Robot System
FREMONT, Calif. and DRAPER, Utah, May 10, 2021 /PRNewswire/ — THINK Surgical, Inc., an innovator in the field of orthopedic active robot surgery, and…
Read More » -
Extremities
Paragon 28, Inc. Receives FDA Clearance and Successfully Completes First MAVEN™ Patient-Specific Instrumentation Surgery
MAVEN PSI delivers breakthrough technology designed to improve the surgeon experience and post-operative outcomes. ENGLWOOD, Colo., May 4, 2021 /PRNewswire/ — Paragon…
Read More » -
Spine
NGMedical GmbH Receives FDA Clearance for its BEE® HA Cervical Cage System made from PEEK-OPTIMATM HA Enhanced
NGMedical, a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application announces FDA clearance for its…
Read More »