Amedica Corporation, a spinal and reconstructive medical device manufacturer, announced today it has received FDA 510(k) clearance to legally market a second generation family of cervical and lumbar interbody fusion devices manufactured with the company’s proprietary Silicon Nitride biomaterial. The product offers design enhancements the company says will allow surgeons to perform minimally invasive and lumbar lateral interbody fusion approaches.
FDA Approval
Newly Cleared ReForm™ Pedicle Screw System Represents A Metamorphosis In Pedicle Screw, Rod And Instrumentation Technology
New Jersey device company Precision Spine, Inc. has announced that it has received 510(k) clearance from the FDA its ReForm Pedicle Screw System. Physician/Developer says it will increase efficiency of application and ease ergonomic use.
FDA 510(k) Clearance For Teleflex ARROW® FlexBlock™ Continuous Peripheral Nerve Block Catheter
Device company Teleflex Inc. has announced the FDA 510(k) clearance of its Arrow® FlexBlock continuous peripheral nerve block catheter designed for clinicians who use ultrasound guidance when placing peripheral nerve block catheters.
Intelomed Receives FDA 510(k) Clearance For CVInsight Medical Device
Intelomed, Inc., has announced that it has received FDA 510(k) clearance for its CVInsight medical device which measures and displays vital information such as functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate of adult and pediatric patients.
FDA 510(k) Clearance For NLT Spine’s eSPIN™ Discectomy System
NLT Spine’s eSPIN and PROW FUSION™ Together Offer a Complete Lumbar Interbody Fusion Procedure. FDA clearance means the system is good to go.
FDA Clears Thoracic-Length Aptus HeliFX™ Aortic Securement System
EVAR specialist Aptus Endosystems, Inc., has received 510(k) clearance from the U.S. FDA for its thoracic-length HeliFX™ Aortic Securement System.
Pediatric Clearance Sees K2M’s MESA® & Rail 4D™ Spinal Systems Indicated For Adolescent Idiopathic Scoliosis
K2M focuses its efforts on developing devices to address complex spine disorders, so will be delighted to have gained an extended FDA clearance for its clever spinal rod system, which can now be used in adolescent idiopathic scoliosis.
South Korean Knee Prosthesis Gains FDA Clearance
South Korean manufactured Lospa Knee® System from Corentec features cruciate retaining and posterior stabilised knee within a single system
Precision Spine, Inc. Announces FDA Approval for Slimplicity® Solo Anterior Cervical Plate System
Precision Spine subsidiary Spinal USA, Inc., has received 510(k) clearance from the FDA for the Slimplicity® Solo Anterior Cervical Plate System, adding another important cervical product to its broad and expanding product portfolio.
Teleflex’s New Arrow®PICC System Aims At Zero Complication Catheter Placement
Teleflex says its Arrow® VPS replaces the need for confirmatory chest X-ray by using state-of-the-art, real-time intravascular Doppler, ECG and advanced algorithmic logic to notify the clinician that the central catheter tip has reached the optimal location.
FDA Clears Covidien’s LigaSure™ Small Jaw Sealer/Divider For ENT Use
Covidien has announced that it has received 510(k) clearance from the U.S. FDA for its LigaSure™ curved, small jaw, open sealer/divider surgical instrument to be used in ear, nose and throat (ENT) procedures.
FDA Approves AF Ablation Device, But Not Yet For Use As An AF Ablation Device
Estech’s breakthrough technology for the first time combines the benefits of a bipolar clamp with the flexibility of an endoscopically guided probe with the capability of creating linear lesions anywhere on a beating heart. It’s for investigational use in AF ablation treatment in U.S right now.
Preventice receives FDA clearance to market BodyGuardian Remote Monitoring System™
Preventice™, Inc., a leading developer of mobile health applications and remote monitoring systems, announced today that the U.S. FDA has given the company 510(k) clearance for its BodyGuardian Remote Monitoring System.
FDA Approves Abiomed’s Higher Flow Impella®
Abiomed Receives FDA 510(k) Clearance for New, Higher Flow Impella Percutaneous Heart Pump, With Peak Flows of 4L/min
LOQTEQ® Trauma Plating System Gets Initial 510(k). More To Follow
Trauma and biomaterials company aap Implantate AG. has announced that it has received 510(k) clearance from the U.S FDA for the small fragment plating line of its Loqteq® product family.
LDR Says Its Newly FDA Cleared Avenue® L Lateral Lumbar Cage System Represents The Pinnacle Of Lumbar Fusion
Spinal implant company LDR has announced FDA 510(k) clearance for its Avenue L Lumbar cage system which it says is the first lateral zero-profile lumbar cage with integrated in-line plating featuring self-guided VerteBRIDGE® plating technology.