FDA (510)k Clearance
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Regulatory
OrthoPediatrics Corp. Receives FDA 510(k) Clearance for Next Generation Cannulated Screw System
WARSAW, Ind., July 23, 2019 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ: KIDS), a company focused exclusively on advancing the field of…
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Regulatory
First System for Dynamic Intra-operative Measurement of Segmental and Global Spine Alignment Receives FDA Clearance
ATLANTA, July 22, 2019 /PRNewswire/ — MiRus is pleased to announce FDA 510(k) clearance of the GALILEO™ Spine Alignment Monitoring System, a non-optical,…
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Regulatory
FDA Clears nView Medical’s 1st Imaging System, nView s1
SALT LAKE CITY (PRWEB) JULY 13, 2019 nView medical Inc. (nView) today announced the U.S. Food and Drug Administration (FDA) clearance…
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OSN Premium
icotec AG Granted FDA Clearance To Market VADER®one Pedicle Screw System
ALTSTAETTEN, Switzerland, July 8, 2019 /PRNewswire/ — icotec AG, a Swiss company, today announced the VADER®one pedicle screw system was granted U.S. Food and…
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Regulatory
Benvenue Medical Receives FDA Clearance for Luna XD Minimally Invasive Expandable Interbody Device
June 27, 2019 SANTA CLARA, Calif.–(BUSINESS WIRE)–Benvenue Medical, Inc., an innovative developer of minimally invasive surgery (MIS) expandable implant solutions…
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Regulatory
Innovasis Announces FDA 510(k) Clearance of LxHA™ Lateral Interbody Fusion Device
SALT LAKE CITY, June 25, 2019 –Innovasis, Inc. an integrated research, development and manufacturing spinal device company, received 510(k) clearance…
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Regulatory
Life Spine Announces FDA 510(k) Clearance of the PROLIFT® Lateral Expandable Spacer System
June 18, 2019 HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the…
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Extremities
Ignite Orthopedics Announces First 510(k) Clearance and Company’s Surgeon Development Team
WARSAW, IND. (PRWEB) JUNE 04, 2019 Ignite Orthopedics LLC, a privately held product development and commercialization organization located in the “Orthopedic…
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Regulatory
Zavation Gains US FDA Clearance for the Ti3Z Interbody System (TLIF, T-PLIF, and PLIF)
FLOWOOD, Miss., June 4, 2019 /PRNewswire/ — Zavation, an employee-owned medical device company that designs, develops, manufactures and distributes medical device products, announced today…
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Hospitals
Medivis Wins FDA Clearance for Breakthrough Augmented Reality Surgical System
NEW YORK, May 30, 2019 /PRNewswire/ —Medivis announced today that its groundbreaking augmented reality (AR) technology platform for surgical applications, SurgicalAR, has received…
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Regulatory
ChoiceSpine™ Granted FDA Clearance for Two New Cervical Spinal Fusion Devices
KNOXVILLE, TENN. (PRWEB) MAY 14, 2019 ChoiceSpine LLC, a privately-held spinal device manufacturer based in Knoxville, TN, was granted 510(k) clearance…
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Regulatory
Astura Medical Receives FDA 510(k) Clearance For HALF DOME X Expandable Posterior Lumbar Interbody System
CARLSBAD, CA – May 3, 2019 – Astura Medical, a high-growth, innovative spine technology company, today announced that it has received…
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Regulatory
SI-BONE, Inc. Announces FDA Clearance of iFuse Bedrock™ Novel Spinopelvic Fixation Technology
SANTA CLARA, Calif., April 15, 2019 (GLOBE NEWSWIRE) — SI-BONE, Inc. (Nasdaq: SIBN), a Silicon Valley based medical device company…
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Biologics
Collagen Matrix, Inc. Receives FDA 510(k) Clearance of a Bioactive Moldable Bone Graft Matrix
OAKLAND, N.J., April 12, 2019 /PRNewswire/ — Collagen Matrix, Inc., a leader in regenerative medicine and a global manufacturer of collagen and mineral…
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Regulatory
ChoiceSpine™ Granted Expanded FDA Clearance for HAWKEYE™ Ti VBR Device
KNOXVILLE, TENN. (PRWEB) APRIL 02, 2019 ChoiceSpine LLC, a privately-held spinal device manufacturer based in Knoxville, TN, was granted 510(k) clearance…
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