The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Threaded Cement Restrictor (cr) Titanium.
| Device ID | K011443 |
| 510k Number | K011443 |
| Device Name: | THREADED CEMENT RESTRICTOR (CR) TITANIUM |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard Treharne |
| Correspondent | Richard 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 | 2001-05-11 |
| Decision Date | 2001-08-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885074000770 | K011443 | 000 |