Name: Predicase
Price: 199 USD

K-number	K162903
Device name	Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies
Applicant	Exactech, Inc.
Product code	KWT
Device class	Class II
Decision date	Feb 27, 2017
Decision	Substantially Equivalent
Regulation	888.3650

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Source

View the full FDA submission: accessdata.fda.gov

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Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies

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