FDA 510(k)

EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages

Número K: K170503 · 2017-07-11

RequerenteEit Emerging Implant Technologies GmbH

Data da decisão2017-07-11

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages is the device name listed in this FDA 510(k) record. The listed applicant is Eit Emerging Implant Technologies GmbH. It received FDA 510(k) clearance on 2017-07-11 under 510(k) number K170503. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages?

EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages is a medical device that received FDA 510(k) clearance on 2017-07-11. The listed applicant is Eit Emerging Implant Technologies GmbH. The 510(k) number is K170503.

When did EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages receive FDA 510(k) clearance?

EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages received FDA 510(k) clearance on 2017-07-11, under 510(k) number K170503.

Who is the listed applicant for EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages?

The FDA 510(k) record lists Eit Emerging Implant Technologies GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages?

The FDA product code for EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages is MAX.

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Outros registros que listam Eit Emerging Implant Technologies GmbH como candidato(a)

K201605EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage K183447EIT Cellular Titanium Lumbar Cage - T/PLIF K181644EIT Cellular Titanium® Lumbar Cage LLIF K172888EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages

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Fonte oficial

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