The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Titanium Cement Restrictor Material Pldla.
| Device ID | K010529 |
| 510k Number | K010529 |
| Device Name: | TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-23 |
| Decision Date | 2001-04-27 |