FDA 510(k)

G21 Cement, VADER® Pedicle System

K-Number: K200596 · 2020-10-13

Decision Date2020-10-13

Product CodePML

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

G21 Cement, VADER® Pedicle System is a medical device manufactured by Icotec AG. It received FDA 510(k) clearance on 2020-10-13 under approval number K200596. 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 G21 Cement, VADER® Pedicle System?

G21 Cement, VADER® Pedicle System is a medical device that received FDA 510(k) clearance on 2020-10-13. It is manufactured by Icotec AG. The 510(k) number is K200596.

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

G21 Cement, VADER® Pedicle System received FDA 510(k) clearance on 2020-10-13, under approval number K200596.

What company makes G21 Cement, VADER® Pedicle System?

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

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

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

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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 K200235KONG-TL VBR System, KONG-C VBR System K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0

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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.