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FDA 510(k)

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

K-Number: K180078 · 2018-04-17

ApplicantInnovasis, Inc.
Decision Date2018-04-17
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Innovasis, Inc.. The 510(k) number is K180078.

When was Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System approved by the FDA?

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

What company makes 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 manufactured by Innovasis, Inc..

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.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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