The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Titanium Cement Restrictor Material Peek.
| Device ID | K010528 |
| 510k Number | K010528 |
| Device Name: | TITANIUM CEMENT RESTRICTOR MATERIAL PEEK |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard W Treharne |
| Correspondent | Richard W Treharne MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-23 |
| Decision Date | 2001-10-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902872693 | K010528 | 000 |