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)

CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G

K-Number: K112907 · 2011-12-22

ApplicantMedos International SARL
Decision Date2011-12-22
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2011-12-22 under 510(k) number K112907. 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 CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G?

CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G is a medical device that received FDA 510(k) clearance on 2011-12-22. The listed applicant is Medos International SARL. The 510(k) number is K112907.

When did CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G receive FDA 510(k) clearance?

CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G received FDA 510(k) clearance on 2011-12-22, under 510(k) number K112907.

Who is the listed applicant for CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G?

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

What is the FDA product code for CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G?

The FDA product code for CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G 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 Medos International SARL 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.

K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyK260240SYMPHONY Navigation Ready InstrumentsK253249TriALTIS™ Spine SystemK243249TriALTIS™ Spine SystemK241893CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysK242042TriALTIS™ Spine System

View all 90 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.

↑