FDA 510(k)

PHA S1 Spinal System

Número K: K163011 · 2017-06-29

Data da decisão2017-06-29

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

PHA S1 Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Phamedica, Inc.. It received FDA 510(k) clearance on 2017-06-29 under 510(k) number K163011. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PHA S1 Spinal System?

PHA S1 Spinal System is a medical device that received FDA 510(k) clearance on 2017-06-29. The listed applicant is Phamedica, Inc.. The 510(k) number is K163011.

When did PHA S1 Spinal System receive FDA 510(k) clearance?

PHA S1 Spinal System received FDA 510(k) clearance on 2017-06-29, under 510(k) number K163011.

Who is the listed applicant for PHA S1 Spinal System?

The FDA 510(k) record lists Phamedica, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHA S1 Spinal System?

The FDA product code for PHA S1 Spinal System is NKB.

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