K-number	K222936
Device name	Humeris® 135 Shoulder System
Applicant	Fx Shoulder USA, Inc.
Product code	PHX
Device class	Class II
Decision date	Nov 7, 2022
Decision	Substantially Equivalent
Regulation	888.3660

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Source

View the full FDA submission: accessdata.fda.gov

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Humeris® 135 Shoulder System

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