FDA 510(k)

DePuy Synthes T-PAL Spacer System

Número K: K181231 · 2018-12-06

Data da decisão2018-12-06

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

DePuy Synthes T-PAL Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Synthes Spine. It received FDA 510(k) clearance on 2018-12-06 under 510(k) number K181231. 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 DePuy Synthes T-PAL Spacer System?

DePuy Synthes T-PAL Spacer System is a medical device that received FDA 510(k) clearance on 2018-12-06. The listed applicant is Depuy Synthes Spine. The 510(k) number is K181231.

When did DePuy Synthes T-PAL Spacer System receive FDA 510(k) clearance?

DePuy Synthes T-PAL Spacer System received FDA 510(k) clearance on 2018-12-06, under 510(k) number K181231.

Who is the listed applicant for DePuy Synthes T-PAL Spacer System?

The FDA 510(k) record lists Depuy Synthes Spine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DePuy Synthes T-PAL Spacer System?

The FDA product code for DePuy Synthes T-PAL Spacer System is MAX.

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Outros registros que listam Depuy Synthes Spine como candidato(a)

K183054SYNMESH System

Dispositivos Relacionados (Código: MAX)

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