The following data is part of a premarket notification filed by Medtronic Sofamor Danek, Inc. with the FDA for Titanium Cement Restrictor (tcr).
| Device ID | K003718 |
| 510k Number | K003718 |
| Device Name: | TITANIUM CEMENT RESTRICTOR (TCR) |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-04 |
| Decision Date | 2001-02-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00721902500060 | K003718 | 000 |