K-number	K191318
Device name	AEQUALIS FLEX REVIVE Shoulder System
Applicant	Tornier, Inc.
Product code	KWS
Device class	Class II
Decision date	Jun 14, 2019
Decision	Substantially Equivalent
Regulation	888.3660

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Source

View the full FDA submission: accessdata.fda.gov

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AEQUALIS FLEX REVIVE Shoulder System

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