K101168 is an FDA 510(k) clearance for the LEGEND POWER ADAPTER MODEL: 6475000. This device is classified as a Motor, Drill, Pneumatic (Class II - Special Controls, product code HBB).
Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on August 24, 2010, 120 days after receiving the submission on April 26, 2010.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4370.
| 510(k) Number | K101168 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2010 |
| Decision Date | August 24, 2010 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBB — Motor, Drill, Pneumatic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4370 |