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FDA 510(k)

icotec Cervical Cage

K-Number: K192897 · 2020-03-20

ApplicantIcotec AG
Decision Date2020-03-20
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

icotec Cervical Cage is the device name listed in this FDA 510(k) record. The listed applicant is Icotec AG. It received FDA 510(k) clearance on 2020-03-20 under 510(k) number K192897. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the icotec Cervical Cage?

icotec Cervical Cage is a medical device that received FDA 510(k) clearance on 2020-03-20. The listed applicant is Icotec AG. The 510(k) number is K192897.

When did icotec Cervical Cage receive FDA 510(k) clearance?

icotec Cervical Cage received FDA 510(k) clearance on 2020-03-20, under 510(k) number K192897.

Who is the listed applicant for icotec Cervical Cage?

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 icotec Cervical Cage?

The FDA product code for icotec Cervical Cage is ODP.

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: ODP)

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.

K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker SpineK254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLCK260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, 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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