FDA 510(k)

Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System

Numéro K : K180078 · 2018-04-17

Date de décision2018-04-17

Code produitMAX

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System is the device name listed in this FDA 510(k) record. The listed applicant is Innovasis, Inc.. It received FDA 510(k) clearance on 2018-04-17 under 510(k) number K180078. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System?

Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System is a medical device that received FDA 510(k) clearance on 2018-04-17. The listed applicant is Innovasis, Inc.. The 510(k) number is K180078.

When did Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System receive FDA 510(k) clearance?

Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System received FDA 510(k) clearance on 2018-04-17, under 510(k) number K180078.

Who is the listed applicant for Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System?

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

What is the FDA product code for Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System?

The FDA product code for Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System is MAX.

Essais cliniques associés

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Source officielle

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