globus coalition agx


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.
Please see the ASTM F2503-13 standard for more information. To give you the best possible experience, this site uses cookies and by continuing to use the site you agree that we can save them on your device. The date on which a device is manufactured.

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.

Organization accredited by FDA to operate a system for the issuance of UDIs. The number assigned to one or more device(s) that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits. Dimension type for the clinically relevant measurement of the medical device. This information may 1) be on a label attached to a durable device, 2) be on a package of a disposable device, or 3) appear in labeling materials of an implantable device. in accordance with our privacy policies. The COALITION AGX™ Spacer is intended to be used with supplemental fixation such as the COALITION AGX™ Plate, ASSURE®, PROVIDENCE™, VIP®, XTEND®, or UNIFY™ Anterior Cervical Plate Systems. Indicates the low value for storage and handling requirements. Classification for devices issued by the FDA. Biomechanically comparable to a traditional ACDF plate at 1-level.*. Name associated with the three-letter Product Code. 73 . Copyright © 2020 Becker's Healthcare. The system streamlines the entire ACDF procedure and facilitates a less invasive approach through a small incision with less retraction. Precisely machined from cortical bone to support cervical loads while maximizing graft volume, Radiolucent for visualization, with tantalum markers to assist in placement. Totals listed account for all payments during the 2018 calendar year. Number of medical devices in the base package. The version or model identifies all devices that have specifications, performance, size, and composition within limits set by the labeler. Indicates storage and handling requirements that are required for the device including temperature, humidity, and atmospheric pressure. 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. Indicates the medical device is free from viable microorganisms. Email for the Customer contact; To be used by patients and consumers for device-related questions. Indicates whether the package is in commercial distribution as defined under 21 CFR 807.3(b). Indicates that the device is a convenience, combination, in vitro diagnostic (IVD), or medical procedure kit. If you think somebody is violating your copyrights and want to notify us, you can find information payments related to this device in 2018. The date by which the label of a device states the device must or should be used. To give you the best possible experience, this site uses cookies and by continuing to use the site you agree that we can save them on your device. $113K. COALITION is an integrated plate and spacer system designed to provide the biomechanical strength of a traditional ACDF with less disruption of patient anatomy and preserved anatomical profile, according to the release.The COALITION technology combines a PEEK interbody spacer with a titanium alloy plate and two titanium alloy screws. Brand Name: COALITION AGX Version or Model: 1128.1526 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: GLOBUS MEDICAL, INC. Primary DI Number: 00889095070705 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 … Allows for allograft or PEEK spacer options based on surgical preference and patient factors. Device Classification Name: intervertebral fusion device with bone graft, cervical: 510(k) Number: K173115: Device Name: COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS Numeric value for the clinically relevant size measurement of the medical device. 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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.

3 Paths to Adopting AI & Automation: Point Solution, Proof of Concept or Enterprise-Wide? The COALITION AGX™ Plate can be used with your preferred cervical interbody spacer such as the COALITION AGX™ Spacer, HEDRON IC™ Spacer, COLONIAL®, HEDRON C™, SUSTAIN® Medium, or FORGE®. To give you the best possible experience, this site uses cookies and by continuing to use the site you agree that we can save them on your device. Globus Medical, Inc. Kelly J. Baker, Ph.D. Senior Vice President, Regulatory and Clinical Affairs Valley Forge Business Center 2560 General Armistead Avenue Audubon, Pennsylvania 19403 Re: K152022 Trade/Device Name: SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R … APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY. All Rights Reserved. The system offers three anatomical footprints, two sagittal profiles and fixed and variable angle screws in both self-drilling and self-tapping options.Read the Globus release about the COALITION ACDF Spacer System.

See 21 CFR 807.3(b) for exceptions.

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