The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Powerease System.
| Device ID | K182436 |
| 510k Number | K182436 |
| Device Name: | POWEREASE System |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Ankit K. Shah |
| Correspondent | Ankit K. Shah Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
| Product Code | HBE |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-07 |
| Decision Date | 2018-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169868724 | K182436 | 000 |
| 00763000025199 | K182436 | 000 |
| 00763000015305 | K182436 | 000 |