K-number	K181348
Device name	Cartiva SCI Disposable Instrumentation Set
Applicant	Cartiva, Inc.
Product code	QBO
Device class	Class II
Decision date	Jun 20, 2018
Decision	Substantially Equivalent
Regulation	888.4505

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Source

View the full FDA submission: accessdata.fda.gov

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Cartiva SCI Disposable Instrumentation Set

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