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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 the device name listed in this FDA 510(k) record. The listed applicant is Icotec AG. It received FDA 510(k) clearance on 2023-01-09 under 510(k) 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. The listed applicant is Icotec AG. The 510(k) number is K222789.

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

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

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

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 VADER® Pedicle System, G21 Cement?

The FDA product code for VADER® Pedicle System, G21 Cement 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 CementSpineartK221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.

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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