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)

SOLITAIRE-C CERVICAL SPACER SYSTEM

K-Number: K113796 · 2012-04-26

ApplicantEbi, LLC
Decision Date2012-04-26
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SOLITAIRE-C CERVICAL SPACER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ebi, LLC. It received FDA 510(k) clearance on 2012-04-26 under 510(k) number K113796. 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 SOLITAIRE-C CERVICAL SPACER SYSTEM?

SOLITAIRE-C CERVICAL SPACER SYSTEM is a medical device that received FDA 510(k) clearance on 2012-04-26. The listed applicant is Ebi, LLC. The 510(k) number is K113796.

When did SOLITAIRE-C CERVICAL SPACER SYSTEM receive FDA 510(k) clearance?

SOLITAIRE-C CERVICAL SPACER SYSTEM received FDA 510(k) clearance on 2012-04-26, under 510(k) number K113796.

Who is the listed applicant for SOLITAIRE-C CERVICAL SPACER SYSTEM?

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

What is the FDA product code for SOLITAIRE-C CERVICAL SPACER SYSTEM?

The FDA product code for SOLITAIRE-C CERVICAL SPACER SYSTEM is OVE.

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, LLC 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.

K111376CONSTRUX EXTERNAL FIXATION DEVICE

Related Devices (Code: OVE)

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.

K263049SABER-C SystemElevation SpineK261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLCK261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, 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.

↑