The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Medtronic Sofamor Danek Cement Restrictor.
| Device ID | K012255 |
| 510k Number | K012255 |
| Device Name: | MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne MEDTRONIC SOFAMOR DANEK, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-18 |
| Decision Date | 2001-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902170898 | K012255 | 000 |
| 00721902170874 | K012255 | 000 |
| 00721902170645 | K012255 | 000 |
| 00721902170638 | K012255 | 000 |