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)

Cervical Stand-Alone System

K-Number: K212853 · 2021-11-05

ApplicantEminent Spine, LLC
Decision Date2021-11-05
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cervical Stand-Alone System is a medical device manufactured by Eminent Spine, LLC. It received FDA 510(k) clearance on 2021-11-05 under approval number K212853. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cervical Stand-Alone System?

Cervical Stand-Alone System is a medical device that received FDA 510(k) clearance on 2021-11-05. It is manufactured by Eminent Spine, LLC. The 510(k) number is K212853.

When was Cervical Stand-Alone System approved by the FDA?

Cervical Stand-Alone System received FDA 510(k) clearance on 2021-11-05, under approval number K212853.

What company makes Cervical Stand-Alone System?

Cervical Stand-Alone System is manufactured by Eminent Spine, LLC.

What is the FDA product code for Cervical Stand-Alone System?

The FDA product code for Cervical Stand-Alone System is OVE.

Related Clinical Trials

NCT05701917 DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING NCT05677100 Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure RECRUITING NCT07544654 DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy NOT_YET_RECRUITING NCT07382674 Zesty Exercise System for Therapeutic Engagement RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED

Other Devices by Eminent Spine, LLC

K201979Cervical Plate System K230219Eminent Spine 3D Lumbar Interbody Fusion Systems K240505Eminent Spine SI Screw System

Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, 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.

↑