K-number	K153248
Device name	PEEK Customized Cranial Implant
Applicant	Stryker
Product code	GWO
Device class	Class II
Decision date	Mar 10, 2016
Decision	Substantially Equivalent
Regulation	882.5320

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Source

View the full FDA submission: accessdata.fda.gov

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PEEK Customized Cranial Implant

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