Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Edge Upper Cervical System

K-Number: K221307 · 2023-07-10

ApplicantSpinal Simplicity, LLC
Decision Date2023-07-10
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Edge Upper Cervical System is a medical device manufactured by Spinal Simplicity, LLC. It received FDA 510(k) clearance on 2023-07-10 under approval number K221307. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Edge Upper Cervical System?

Edge Upper Cervical System is a medical device that received FDA 510(k) clearance on 2023-07-10. It is manufactured by Spinal Simplicity, LLC. The 510(k) number is K221307.

When was Edge Upper Cervical System approved by the FDA?

Edge Upper Cervical System received FDA 510(k) clearance on 2023-07-10, under approval number K221307.

What company makes Edge Upper Cervical System?

Edge Upper Cervical System is manufactured by Spinal Simplicity, LLC.

What is the FDA product code for Edge Upper Cervical System?

The FDA product code for Edge Upper Cervical System is NKG.

Related Clinical Trials

NCT07610850 Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation NOT_YET_RECRUITING NCT07137728 Dual Frequency Low-Level Laser Therapy in Myofascial Trigger Points of Upper Trapezius COMPLETED NCT06690658 Self-Practicing Upper Body Exercises With a Robotic Trainer System RECRUITING NCT06164808 Cardiac Arrhythmia Telemetry; Conventional vs HeartWatch RECRUITING NCT06087445 A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia COMPLETED NCT07607899 Virtual Reality for Pain and Well-Being in Older Adults NOT_YET_RECRUITING

Other Devices by Spinal Simplicity, LLC

K200066Posterior Fusion Plate, HA Posterior Fusion Plate K212781Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate K221023Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 K211880Minuteman G5 MIS Fusion Plate K231923Liberty SI Lateral Implant System K233527Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate

View all 12 devices →

Related Devices (Code: NKG)

K161032neon3™ universal OCT spinal stabilizationUlrich GmbH & Co. KG K162300Reform® POCT SystemPrecision Spine, Inc. K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. K161478Xenco Medical Posterior Cervical SystemXenco Medical, LLC K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑