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FDA 510(k)

VADER® Pedicle System

K-Number: K232628 · 2024-02-26

ApplicantIcotec AG
Decision Date2024-02-26
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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 2024-02-26 under 510(k) number K232628. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VADER® Pedicle System?

VADER® Pedicle System is a medical device that received FDA 510(k) clearance on 2024-02-26. The listed applicant is Icotec AG. The 510(k) number is K232628.

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

VADER® Pedicle System received FDA 510(k) clearance on 2024-02-26, under 510(k) number K232628.

Who is the listed applicant for 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 VADER® Pedicle System?

The FDA product code for VADER® Pedicle System is NKB.

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 SystemK230861VADER® Pedicle System Navigated Instruments

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Related Devices (Code: NKB)

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.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., 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.

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