K-number	K180078
Device name	Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System
Applicant	Innovasis, Inc.
Product code	MAX
Device class	Class II
Decision date	Apr 17, 2018
Decision	Substantially Equivalent
Regulation	888.3080

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View the full FDA submission: accessdata.fda.gov

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

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