Investigational Device Exemption
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Spine
Centinel Spine® Completes Enrollment in First-of-its-Kind 2-Level IDE Trial Evaluating prodisc® C Match-the-Disc™ Cervical TDR System
The trial is designed to evaluate the safety and effectiveness of the prodisc C Vivo and prodisc C SK system by comparing…
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Recon
Hip Innovation Technology Announces Initiation of FDA Approved Investigational Device Exemption Study
First U.S. Implantation of its Reverse Hip Replacement System for the Treatment of Total Hip Arthroplasty Completed BOCA RATON, Fla., Jan.…
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Biologics
Cerapedics Completes Enrollment of Pivotal U.S. FDA IDE Study for its P-15L Bone Graft
The ASPIRE study is intended to evaluate the use of P-15L Bone Graft in transforaminal lumbar interbody fusion surgery in…
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Recon
FX Solutions, SAS. [FX Shoulder, Inc.] Completes Easytech Reversed® Stemless IDE Enrollment in the USA
The First-and-Only Completed Stemless Reverse IDE in the USA DALLAS, Jan. 27, 2022 /PRNewswire/ — FX has completed the enrollment for their…
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Recon
Hip Innovation Technology Receives FDA Investigational Device Exemption (IDE) Approval to Initiate Landmark Study of its Reverse Hip Replacement System
HIT’s Reverse Hip Replacement System may Revolutionize Total Hip Replacement Surgery BOCA RATON, Fla., Jan. 18, 2022 /PRNewswire/ — Hip Innovation Technology, LLC…
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Spine
NuVasive Simplify Cervical Disc Data Published In International Journal Of Spine Surgery
Peer-reviewed data results from multi-center FDA Investigational Device Exemption study reiterate disc’s superiority to ACDF SAN DIEGO, Sept. 9, 2021 /PRNewswire/ —…
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Extremities
LimaCorporate Announces First Successful Operation with SMR Stemless Reverse Shoulder Systems in IDE Study
SAN DANIELE DEL FRIULI, Italy, April 20 , 2021 / PRNewswire / – LimaCorporate is proud to announce the successful first surgery for the…
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Recon
LimaCorporate Announces FDA Approval for an Ide Study on Smr Stemless Reverse Shoulder System
UDINE, Italy, Nov. 19, 2020 /PRNewswire/ — LimaCorporate is proud to announce that the U.S. Food and Drug Administration (FDA) has approved the…
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Extremities
Anika Therapeutics Files Investigational Device Exemption to Initiate Phase III Study to Expand Indication of MONOVISC® to Treat Pain Caused by Osteoarthritis of the Hip
BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc., (NASDAQ: ANIK), a leader in products for tissue protection, healing, and repair based on hyaluronic…
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Hospitals
Stimwave Receives FDA Approval for High Frequency IDE Utilizing the World’s First and Only Eight-Electrode, Multi-Programmable Wireless Miniature Injectable Stimulator
MIAMI–(BUSINESS WIRE)–Stimwave Technologies Incorporated, a medical device manufacturer and independent research institute, today announced it has received FDA Investigational Device…
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