Name: Predicase
Price: 199 USD

K-number	K213110
Device name	AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor
Applicant	Auxein Medical Private Limited
Product code	MBI
Device class	Class II
Decision date	Dec 16, 2022
Decision	Substantially Equivalent
Regulation	888.3040

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Source

View the full FDA submission: accessdata.fda.gov

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AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor

Everything you need for a 510(k) submission. Nothing you don't.