510(k) K101168
K101168 is an FDA 510(k) premarket notification submitted by Medtronic Sofamor Danek for the device "LEGEND POWER ADAPTER MODEL: 6475000". The FDA issued a decision of Substantially Equivalent on August 24, 2010. The device falls under product code HBB (Motor, Drill, Pneumatic), a Class II device regulated under 21 CFR 882.4370. Medtronic Sofamor Danek has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 2010
- Date Received
- April 26, 2010
- 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