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 ESL SPINE SPACER SYSTEM

K-Number: K040482 · 2004-04-16

ApplicantEbi, L.P.
Decision Date2004-04-16
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EBI ESL SPINE SPACER 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 2004-04-16 under 510(k) number K040482. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBI ESL SPINE SPACER SYSTEM?

EBI ESL SPINE SPACER SYSTEM is a medical device that received FDA 510(k) clearance on 2004-04-16. The listed applicant is Ebi, L.P.. The 510(k) number is K040482.

When did EBI ESL SPINE SPACER SYSTEM receive FDA 510(k) clearance?

EBI ESL SPINE SPACER SYSTEM received FDA 510(k) clearance on 2004-04-16, under 510(k) number K040482.

Who is the listed applicant for EBI ESL SPINE SPACER 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 ESL SPINE SPACER SYSTEM?

The FDA product code for EBI ESL SPINE SPACER SYSTEM is MQP.

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: MQP)

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.

K261810Vertiwedge® Intraosseous SystemFoundation Surgical GroupK261031POSEIDON STSignus Medinzintechnik GmbHK253158VyBrate™ VBR SystemVy Spine, LLCK241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AGK233359DOMINION Expandable Corpectomy SystemAstura Medical

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.

↑