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)

AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020

K-Number: K093463 · 2010-02-26

ApplicantCare Fusion
Decision Date2010-02-26
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020 is the device name listed in this FDA 510(k) record. The listed applicant is Care Fusion. It received FDA 510(k) clearance on 2010-02-26 under 510(k) number K093463. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020?

AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020 is a medical device that received FDA 510(k) clearance on 2010-02-26. The listed applicant is Care Fusion. The 510(k) number is K093463.

When did AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020 receive FDA 510(k) clearance?

AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020 received FDA 510(k) clearance on 2010-02-26, under 510(k) number K093463.

Who is the listed applicant for AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020?

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

What is the FDA product code for AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020?

The FDA product code for AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020 is NDN.

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 Care Fusion 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.

K233021BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access DeviceK231888BD Texium™ Needle-Free SyringeK221319BD Alaris™ Pump Epidural Infusion SetK221327BD Alaris™ Pump Infusion SetsK223101BD Secondary Infusion SetK223088BD SmartSite™ Needle-Free Connector

View all 27 devices →

Related Devices (Code: NDN)

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.

K251896XeliteMed SuperM-Fix Spinal Bone CementXelite Biomed , Ltd.K250637VCFix Spinal SystemAmber ImplantsK243537XeliteMed VertehighFix High Viscosity Spinal Bone Cement SystemXelite Biomed , Ltd.K241775XeliteMed VertehighFix High Viscosity Spinal Bone CementXelite Biomed , Ltd.K232842Balloon Inflation SystemNingbo Hicren Biotechnology Co., Ltd.K240084V-STRUT® Vertebral ImplantHyprevention

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.

↑