510(k) K072315
K072315 is an FDA 510(k) premarket notification submitted by Medtronic Powered Surgical Solutions for the device "MIDAS REX CURVED BUR". The FDA issued a decision of Substantially Equivalent on September 18, 2007. The device falls under product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), a Class II device regulated under 21 CFR 882.4310. Medtronic Powered Surgical Solutions has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 2007
- Date Received
- August 20, 2007
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drills, Burrs, Trephines & Accessories (Simple, Powered)
- Device Class
- Class II
- Regulation Number
- 882.4310
- Review Panel
- NE
- Submission Type