K-number	K161407
Device name	Ascential IBD PEEKc Spacer
Applicant	Stryker Spine
Product code	ODP
Device class	Class II
Decision date	Jul 15, 2016
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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Ascential IBD PEEKc Spacer

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