Available in two distinct profiles, the plate offers the benefits of a standard cervical plate, while allowing less disruption to patient anatomy. Virtual Primary Care - Essential for the evolution of healthcare, Half of EDs aren't fully equipped to treat emergency pediatric patients — 6 steps to enhance emergency care for children, 5 elements of a successful ED transformation, Firewalls won't fully protect hospital networks: 7 common vulnerabilities, The cybersecurity trends health systems need to know — 8 tips to minimize exposure, The internet of things and blockchain — Current and future real-world opportunities in healthcare, How Banner Health transforms data into savings — Key learnings from Banner's supply chain success, How workforce management and staff empowerment go hand-in-hand at leading health systems, Change management amid COVID-19: Urgent pivots, lasting transformations and unanswered questions, 2020 Physician & Consumer Telehealth Survey, Digital transformation shouldn't just change where you deliver care, but how — essentials for optimized virtual care, ASC Annual Meeting: The Business and Operations of ASCs, Health IT + Clinical Leadership + Pharmacy Conference, Spine, Orthopedic and Pain Management-Driven ASC + the Future of Spine Conference. The procedure is streamlined by low profile instrumentation which facilitates a less invasive approach through a smaller incision. Indicates that the product contains or consists of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient as defined under 21 CFR 1271.3.
This date is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined. By using our Services, you agree that www.HIPAASpace.com can use such data Product Overview. A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD).
This number is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined.
Integrated plate and spacer is designed to preserve the natural anatomical profile of the spine. We respond to notices of alleged copyright infringement and terminate accounts of repeat infringers Indicates that the device requires a prescription to use. View our policies by clicking here.
All registered trademarks, used in the content, are the property of their owners. Cages falling under this category include: Centinel Spine’s STALIF TT™ and STALIF C™, Medtronic’s Sovereign® and Prevail®, Synthes’s Zero-P, LDR’s ROI-C®, and Globus’s Independence® and Coalition… The COALITION ® spacer is an integrated stand-alone plate-spacer that provides the biomechanical strength of a traditional ACDF while minimizing disruption to patient anatomy. Definition of the common device type associated with the GMDN Preferred Term Code/FDA PT Code. 0 . Indicates the date this particular package configuration is discontinued by the labeler. This date is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined. All rights reserved.
HIPAA liability, trademark, document use and software licensing rules apply. Globus Medical Inc. Kelly J. Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Avenue Audubon, Pennsylvania 19403 Re: K173115 Trade/Device Name: COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral … Interested in linking to or reprinting our content? The device may or may not still be available for purchase in the marketplace. Biomechanically comparable to a traditional 2-level ACDF (spacer and plate).*. © Copyright ASC COMMUNICATIONS 2020. Company name associated with the labeler DUNS Number entered in the DI Record.
Labeling does not contain MRI Safety Information. Indicates the high value for storage and handling requirements. Indicates that the device requires sterilization prior to use. The COALITION AGX™ Spacer is an anterior cervical interbody fusion spacer made from machined cortical bone, and is also available in radiolucent PEEK polymer. ... GLOBUS MEDICAL, INC. $113K: Top Doctors Receiving Payments Related to this Device.
See 21 CFR 807.3(b) for exceptions.
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