MR8 Drill System
FDA 510(k) clearance K163565 · decided 2017-03-28
Clearance details
- K-number
- K163565
- Device name
- MR8 Drill System
- Applicant
- Medtronic Powered Surgical Solutions
- Decision
- Substantially Equivalent
- Date received
- 2016-12-19
- Decision date
- 2017-03-28
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- HBC
- Device class
- 2
- Regulation number
- 882.4360
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.