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FDA 510(k)

G21 Cement, VADER® Pedicle System

K-Number: K200596 · 2020-10-13

ApplicantIcotec AG
Decision Date2020-10-13
Product CodePML
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

G21 Cement, VADER® Pedicle System is the device name listed in this FDA 510(k) record. The listed applicant is Icotec AG. It received FDA 510(k) clearance on 2020-10-13 under 510(k) 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. The listed applicant is Icotec AG. The 510(k) number is K200596.

When did G21 Cement, VADER® Pedicle System receive FDA 510(k) clearance?

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

Who is the listed applicant for G21 Cement, VADER® Pedicle System?

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

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

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

Other records listing Icotec AG 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.

K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsK242900VADER® Pedicle System and VADER®one Pedicle SystemK233215icotec Anterior Cervical Plate SystemK232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage)K232790KONG®-TL VBR System and KONG® C VBR SystemK232628VADER® Pedicle System

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Related Devices (Code: PML)

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.

K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura MedicalK241034Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw SystemMedacta International S.A.K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone CementUlrich Medical USAK230774PERLA® TL System; TEKTONA® HV US Bone CementSpineartK222789VADER® Pedicle System, G21 CementIcotec AG

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.

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