K-number	K151382
Device name	Patient Contoured Implant-PEEK (PCI-PEEK)
Applicant	KLS Martin L.P.
Product code	GXN
Device class	Class II
Decision date	Nov 9, 2015
Decision	Substantially Equivalent
Regulation	882.5330

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View the full FDA submission: accessdata.fda.gov

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Patient Contoured Implant-PEEK (PCI-PEEK)

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