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MCRA Partner Orthobond Granted De Novo for Innovative Pedicle Screw System with Ostaguard™ Coating

MCRA Partner Orthobond Granted De Novo for Innovative Pedicle Screw System with Ostaguard™ Coating
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MCRA Assists Curiteva Inc. with FDA 510(k) Clearance for Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System

MCRA Assists Curiteva Inc. with FDA 510(k) Clearance for Inspire 3D Printed Trabecular PEEK Lumbar Interbody Fusion System
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3Spine wins FDA IDE for spine implant

3Spine announced today that it received FDA investigational device exemption (IDE) for its Motus spinal implant device. ....

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3Spine, Inc. Announces IDE Approval

3Spine, Inc. Announces IDE Approval
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MCRA CRO Assists Simplify Medical, Recently Acquired by NuVasive, on FDA-Approval for Two Level use of its Cervical Disc

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WASHINGTON, May 12, 2021 /PRNewswire/ MCRA, LLC, the leading privately held medical device and biologics advisory firm and Clinical Research Organization (CRO) integrating U.S. and International Regulatory, Clinical Research, Reimbursement, Healthcare Compliance, Quality Assurance, and Medical Device Cybersecurity, is pleased to announce its role in the successful management and execution of Simplify Medical s two clinical studies and approvals by the U.S. Food and Drug Administration (FDA) for the Simplify Cervical Artificial Disc (Simplify Disc) to be used at one-level and two contiguous levels in the cervical spine.
Abigail Allen, MCRA s Vice President of Clinical Affairs, said, MCRA is honored to have supported Simplify Medical with the approval of their two-level disc just six months after the one-level approval. It has been a true testament to the teamwork and collaboration between the two companies, and all of our sites ....

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