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

FDA 510(k)

VADER® Pedicle System, G21 Cement

K-Number: K222789 · 2023-01-09

ApplicantIcotec AG
Decision Date2023-01-09
Product CodePML
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VADER® Pedicle System, G21 Cement is a medical device manufactured by Icotec AG. It received FDA 510(k) clearance on 2023-01-09 under approval number K222789. The device is classified under product code PML. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VADER® Pedicle System, G21 Cement?

VADER® Pedicle System, G21 Cement is a medical device that received FDA 510(k) clearance on 2023-01-09. It is manufactured by Icotec AG. The 510(k) number is K222789.

When was VADER® Pedicle System, G21 Cement approved by the FDA?

VADER® Pedicle System, G21 Cement received FDA 510(k) clearance on 2023-01-09, under approval number K222789.

What company makes VADER® Pedicle System, G21 Cement?

VADER® Pedicle System, G21 Cement is manufactured by Icotec AG.

What is the FDA product code for VADER® Pedicle System, G21 Cement?

The FDA product code for VADER® Pedicle System, G21 Cement is PML.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT06960018 Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement RECRUITING NCT07408726 Monoaxial vs. Polyaxial Percutaneous Hybrid Stabilization NOT_YET_RECRUITING

Other Devices by Icotec AG

K151977icotec Pedicle System K172480icotec Interbody Cage System K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 K201587icotec Anterior Cervical Plate System K200596G21 Cement, VADER® Pedicle System K200235KONG-TL VBR System, KONG-C VBR System

View all 16 devices →

Related Devices (Code: PML)

K160879CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsMedos International Sàrl K152604KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated K171938KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw SetMedtronic K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated K172269FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw SystemGlobus Medical, Inc. K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics , Ltd.

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.

↑