FDA 510(k)

icotec Interbody Cage System

Número K: K172480 · 2018-05-17

Data da decisão2018-05-17

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

icotec Interbody Cage 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 2018-05-17 under 510(k) number K172480. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the icotec Interbody Cage System?

icotec Interbody Cage System is a medical device that received FDA 510(k) clearance on 2018-05-17. The listed applicant is Icotec AG. The 510(k) number is K172480.

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

icotec Interbody Cage System received FDA 510(k) clearance on 2018-05-17, under 510(k) number K172480.

Who is the listed applicant for icotec Interbody Cage 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 icotec Interbody Cage System?

The FDA product code for icotec Interbody Cage System is ODP.

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Outros registros que listam Icotec AG como candidato(a)

K252327CMORE® CT System; CMORE® CT System Navigated Instruments K242900VADER® Pedicle System and VADER®one Pedicle System K233215icotec Anterior Cervical Plate System K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage)K232790KONG®-TL VBR System and KONG® C VBR System K232628VADER® Pedicle System

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Dispositivos Relacionados (Código: ODP)

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.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 Spine K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.

Fonte oficial

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