MR8 Drill System
K-Number: K163565 · 2017-03-28
Device Summary
Frequently Asked Questions
What is the MR8 Drill System?
MR8 Drill System is a medical device that received FDA 510(k) clearance on 2017-03-28. The listed applicant is Medtronic Powered Surgical Solutions. The 510(k) number is K163565.
When did MR8 Drill System receive FDA 510(k) clearance?
MR8 Drill System received FDA 510(k) clearance on 2017-03-28, under 510(k) number K163565.
Who is the listed applicant for MR8 Drill System?
The FDA 510(k) record lists Medtronic Powered Surgical Solutions as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MR8 Drill System?
The FDA product code for MR8 Drill System is HBC.
Other records listing Medtronic Powered Surgical Solutions as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: HBC)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.