Name: Predicase
Price: 199 USD

K-number	K181752
Device name	Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)
Applicant	Stryker Corporation
Product code	HRX
Device class	Class II
Decision date	Dec 21, 2018
Decision	Substantially Equivalent
Regulation	888.1100

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Source

View the full FDA submission: accessdata.fda.gov

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Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)

Everything you need for a 510(k) submission. Nothing you don't.