The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Powerease System.
| Device ID | K123270 |
| 510k Number | K123270 |
| Device Name: | POWEREASE SYSTEM |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Julie Bassett |
| Correspondent | Julie Bassett MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | HBE |
| Subsequent Product Code | GWF |
| Subsequent Product Code | HWE |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-19 |
| Decision Date | 2013-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169013117 | K123270 | 000 |
| 00643169013100 | K123270 | 000 |