FDA 510(k)

SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant

Numéro K : K152463 · 2016-01-20

Date de décision2016-01-20

Code produitFWP

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant is the device name listed in this FDA 510(k) record. The listed applicant is Poriferous, LLC. It received FDA 510(k) clearance on 2016-01-20 under 510(k) number K152463. The device is classified under product code FWP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant?

SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant is a medical device that received FDA 510(k) clearance on 2016-01-20. The listed applicant is Poriferous, LLC. The 510(k) number is K152463.

When did SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant receive FDA 510(k) clearance?

SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant received FDA 510(k) clearance on 2016-01-20, under 510(k) number K152463.

Who is the listed applicant for SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant?

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

What is the FDA product code for SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant?

The FDA product code for SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant is FWP.

Essais cliniques associés

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Dispositifs connexes (Code : FWP)

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Source officielle

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