K-number	K193394
Device name	Humeral Cup Stability & Humeral Cup 135/145o Stability
Applicant	Fx Shoulder USA, Inc.
Product code	PHX
Device class	Class II
Decision date	Apr 29, 2020
Decision	Substantially Equivalent
Regulation	888.3660

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Source

View the full FDA submission: accessdata.fda.gov

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Humeral Cup Stability & Humeral Cup 135/145o Stability

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