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

FDA 510(k)

EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM

K-Number: K010003 · 2001-01-31

ApplicantEbi, L.P.
Decision Date2001-01-31
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ebi, L.P.. It received FDA 510(k) clearance on 2001-01-31 under 510(k) number K010003. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM?

EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2001-01-31. The listed applicant is Ebi, L.P.. The 510(k) number is K010003.

When did EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM receive FDA 510(k) clearance?

EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM received FDA 510(k) clearance on 2001-01-31, under 510(k) number K010003.

Who is the listed applicant for EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM?

The FDA 510(k) record lists Ebi, L.P. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM?

The FDA product code for EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM is KWQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ebi, L.P. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K100438POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEMK100220POLARIS SPINAL SYSTEMK093880PEANUT GROWTH CONTROL PLATING SYSTEMK092574ESL SPINAL SYSTEMK093057BIOMET VISION FOOTRING SYSTEMK092336C-THRU SPINAL SYSTEM

View all 95 devices →

Related Devices (Code: KWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262149corra® cervical plating systemCarlsmed, Inc.K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC

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.

↑