FDA 510(k)

EIT Cellular Titanium Lumbar Cage - T/PLIF

Número K: K183447 · 2019-02-04

RequerenteEit Emerging Implant Technologies GmbH

Data da decisão2019-02-04

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

EIT Cellular Titanium Lumbar Cage - T/PLIF 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 2019-02-04 under 510(k) number K183447. 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 Lumbar Cage - T/PLIF?

EIT Cellular Titanium Lumbar Cage - T/PLIF is a medical device that received FDA 510(k) clearance on 2019-02-04. The listed applicant is Eit Emerging Implant Technologies GmbH. The 510(k) number is K183447.

When did EIT Cellular Titanium Lumbar Cage - T/PLIF receive FDA 510(k) clearance?

EIT Cellular Titanium Lumbar Cage - T/PLIF received FDA 510(k) clearance on 2019-02-04, under 510(k) number K183447.

Who is the listed applicant for EIT Cellular Titanium Lumbar Cage - T/PLIF?

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 Lumbar Cage - T/PLIF?

The FDA product code for EIT Cellular Titanium Lumbar Cage - T/PLIF is MAX.

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