Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories
FDA 510(k) K163182 · Medtronic Powered Surgical Solutions
510(k) numberK163182
Submission
- Device name
- Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories
- Applicant
- Medtronic Powered Surgical Solutions
Fort Worth, TX, US - Received
- November 14, 2016
- Decision date
- March 23, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K041754 | Stryker Maestro SystemHBB · Traditional | Stryker Corp. | 09/07/2004SE |
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| K213454 | Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8…HBE · Special | 11/23/2021SE |
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| K170312 | IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw…HBC · Traditional | 05/15/2017SE |
| K163565 | MR8 Drill SystemHBC · Traditional | 03/28/2017SE |
| K160713 | Stealth-Midas SystemOLO · Traditional | 05/26/2016SE |
| K090112 | Midas Rex MR7 Pneumatic High Speed System, Models PM700, PM710, PC700, PC710, PC720, PA700HBB · Traditional | 03/26/2009SE |
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Questions and answers
When was Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories cleared by the FDA?
Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories (K163182) received a 510(k) decision of Substantially Equivalent on March 23, 2017, 129 days after the submission was received.
What is the product code of K163182?
The FDA product code is HBB – Motor, Drill, Pneumatic, a Class II (moderate risk) device regulated under 21 CFR 882.4370.