Name: Predicase
Price: 199 USD

K-number	K151500
Device name	Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)
Applicant	Custom Orthopaedic Solutions
Product code	KWS
Device class	Class II
Decision date	Oct 5, 2015
Decision	Substantially Equivalent
Regulation	888.3660

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Source

View the full FDA submission: accessdata.fda.gov

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Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)

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