Name: Predicase
Price: 199 USD

K-number	K214001
Device name	Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System
Applicant	Biomet Manufacturing Corp
Product code	PHX
Device class	Class II
Decision date	Mar 15, 2023
Decision	Substantially Equivalent
Regulation	888.3660

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Source

View the full FDA submission: accessdata.fda.gov

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Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System

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