510(k) K090112
K090112 is an FDA 510(k) premarket notification submitted by Medtronic Powered Surgical Solutions for the device "MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700". The FDA issued a decision of Substantially Equivalent on March 26, 2009. The device falls under product code HBB (Motor, Drill, Pneumatic), a Class II device regulated under 21 CFR 882.4370. Medtronic Powered Surgical Solutions has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 2009
- Date Received
- January 16, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Motor, Drill, Pneumatic
- Device Class
- Class II
- Regulation Number
- 882.4370
- Review Panel
- NE
- Submission Type