K-number	K183515
Device name	MR8 Drill System, Midas Rex MR8 ClearView Tools
Applicant	Medtronic Powered Surgical Solutions
Product code	HBC
Device class	Class II
Decision date	May 12, 2019
Decision	Substantially Equivalent
Regulation	882.4360

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Source

View the full FDA submission: accessdata.fda.gov

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MR8 Drill System, Midas Rex MR8 ClearView Tools

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