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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 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.

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. 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.

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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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