Stealth-Midas MR8 System— 510(k) K183644
Substantially EquivalentMedtronic Powered Surgical Solutions
FDA 510(k) clearance K183644 for Stealth-Midas MR8 System, Substantially Equivalent on 2019-05-22. Applicant: Medtronic Powered Surgical Solutions. Device class: 2.
Clearance details
- Applicant
- Medtronic Powered Surgical Solutions
- Product code
- Code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Worth, TX, US
Recent devices under product code OLO
view allMore clearances from Medtronic Powered Surgical Solutions
view all- K213454 — Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm
- K183515 — MR8 Drill System, Midas Rex MR8 ClearView Tools
- K170312 — IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools
- K163565 — MR8 Drill System
- K163182 — Medtronic Legend Pneumatic +5 more
Adverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.