Name: Predicase
Price: 199 USD

K-number	K142072
Device name	GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)
Applicant	Custom Orthopaedic Solutions, Inc.
Product code	KWS
Device class	Class II
Decision date	Nov 24, 2014
Decision	Substantially Equivalent
Regulation	888.3660

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Source

View the full FDA submission: accessdata.fda.gov

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GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)

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