K-number	DEN220012
Device name	Tornier Pyrocarbon Humeral Head
Applicant	Tornier S.A.S.
Product code	QKW
Device class	Class II
Decision date	Dec 16, 2022
Decision	Not Substantially Equivalent
Regulation	888.3695

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Source

View the full FDA submission: accessdata.fda.gov

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Tornier Pyrocarbon Humeral Head

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