K-number	K193549
Device name	SIGMA High Performance (HP) Partial Knee System
Applicant	Depuy Ireland UC
Product code	HRY
Device class	Class II
Decision date	Apr 16, 2020
Decision	Substantially Equivalent
Regulation	888.3530

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Source

View the full FDA submission: accessdata.fda.gov

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SIGMA High Performance (HP) Partial Knee System

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