The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Legend Power Adapter Model: 6475000.
| Device ID | K101168 |
| 510k Number | K101168 |
| Device Name: | LEGEND POWER ADAPTER MODEL: 6475000 |
| Classification | Motor, Drill, Pneumatic |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Theresa Leister |
| Correspondent | Theresa Leister MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | HBB |
| CFR Regulation Number | 882.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-26 |
| Decision Date | 2010-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994488619 | K101168 | 000 |