13 spine devices receive FDA 510(k) clearance in April

Written by Laura Dyrda | May 10, 2019 | Print  |

The FDA cleared 13 spine-related devices last month.

CREO Stabilization System, Navigation Instruments, ExcelsiusGPS from Globus Medical.

Assure Anterior Cervical Plate System from Globus Medical.

FlareHawk Interbody Fusion System from Integrity Implants.

Pyramesh Implant System from Medtronic Sofamor Danek.

SambaScrew 3D SI Fusion System from Orthofix.

Vitality Spinal Fixation System from Zimmer Biomet Spine.

iFuse Implant System from SI-BONE.

Karma Fixation System from Spinal Elements.

Zavation Spinal System from Zavation Medical Products.

Atlas Plating System from MiRus.

Crossway Spinal Access System from Globus Medical.

ExcelsiusGPS from Globus Medical.

SeaSpine Shoreline ACS Anterior Cervical Standalone System from SeaSpine Orthopedics.

More articles on orthopedic devices:
Boston Scientific makes $465M+ spine acquisition: 5 things to know
Medtronic strengthens spine portfolio with Titan Spine acquisition: 4 details
7 device companies report Q1 results & more: 10 notes

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