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FDA 510(k), K183515, MR8 Drill System, Midas Rex MR8 ClearView Tools
FDA 510(k), K183515, MR8 Drill System, Midas Rex MR8 ClearView Tools
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510(K) Number: K183515
Device Name: MR8 Drill System, Midas Rex MR8 ClearView Tools
Manufacturer: Medtronic Powered Surgical Solutions
Device Classification Name: motor, drill, electric
Regulation Number: 882.4360
Classification Product Code: HBC
Date Received: 12/18/2018
Decision Date: 05/12/2019
Regulation Medical Specialty: Neurology
Device Name: MR8 Drill System, Midas Rex MR8 ClearView Tools
Manufacturer: Medtronic Powered Surgical Solutions
Device Classification Name: motor, drill, electric
Regulation Number: 882.4360
Classification Product Code: HBC
Date Received: 12/18/2018
Decision Date: 05/12/2019
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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