K-number	K232457
Device name	Q-FIX ULTRA All-Suture Anchor
Applicant	Smith & Nephew
Product code	MBI
Device class	Class II
Decision date	Sep 8, 2023
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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Q-FIX ULTRA All-Suture Anchor

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