Name: Predicase
Price: 199 USD

K-number	K212912
Device name	OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System
Applicant	B-One Ortho, Corp.
Product code	MAI
Device class	Class II
Decision date	Nov 4, 2021
Decision	Substantially Equivalent
Regulation	888.3030

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System

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