Premia Spine
Highly Engaged Employees
Manufacturing · United Kingdom · 11-50 Employees
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Overview
Headquarters
5 Roundwood Ln, Harpenden, Hertfordshire...Phone Number
+972 544626602Website
www.premiaspine.comRevenue
$14.9 MillionIndustry
About Premia Spine
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Premia Spine Tech Stack
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Premia Spine News & Media
Premia Spine Launches FDA-Approved TOPS™ System at North American Spine Society
First Facet Replacement to Transform Spinal Treatment of Spinal Stenosis and Spondylolisthesis with Superior Alternative to Traditional Fusion Surgery NORWALK, Conn. , Oct. 11, 2023 /PRNewswire-PRWeb/ -- Premia Spine, an innovator in spine medical devices, announced the commercial launch...Premia Spine Completes FDA Site Inspections With No FDA Observations
NORWALK, Conn.--(BUSINESS WIRE)--Premia Spine, a medical technology company changing the way debilitating chronic leg and back pain is treated, today announced the U.S. Food and Drug Administration (FDA) has completed four Bioresearch Monitoring (BIMO) inspections as part of the PMA approval process for the TOPS facet joint replacement system. The inspections at two company facilities and two clinical trial sites in the U.S. resulted in no FDA Form 483s for objectionable observations. “While aPremia Spine’s TOPS™ Facet Joint Replacement Demonstrates Significant Improvement in All Patient-Reported Outcome Measures Versus Fusion in FDA Trial
NORWALK, Conn.--(BUSINESS WIRE)-- #Spondylolisthesis--Premia Spine, a medical technology company changing the way debilitating chronic leg and back pain is treated, today announced publication of two-year outcomes from the TOPS facet joint replacement system’s clinical trial in the Journal of Neurosurgery Spine. The study, “Prospective, Randomized and Controlled Multicenter Study of Posterior Lumbar Facet Arthroplasty for the Treatment of Spondylolisthesis,” found lumbar facet arthroplasty withPremia Spine’s TOPS™ Facet Replacement Demonstrates Significant Improvement in All Patient-Reported Outcome Measures in FDA Trial
NORWALK, Conn.--(BUSINESS WIRE)-- #Spondylolthesis--Premia Spine, a medical technology company changing the way debilitating chronic leg and back pain is treated, today announced publication of one-year outcomes from the TOPS facet replacement system’s clinical trial in the journal Clinical Spine Surgery. The study, “A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of degenerative Spondylolisthesis and Stenosis: Results from the Total Posterior Spine System (TOPS) IDE Study,” fo
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Frequently Asked Questions Regarding Premia Spine
Premia Spine specializes in innovative spinal surgery implants, particularly the TOPS System, which addresses spinal conditions like spondylolisthesis and spinal stenosis. Their products aim to provide alternatives to traditional fusion surgery, allowing patients to regain mobility without the rigid fixation typical of fusion procedures. Intended c... Read More