The following data is part of a premarket notification filed by Centerpulse Orthopedics, Inc. with the FDA for Durasul Bipolar.
| Device ID | K040947 |
| 510k Number | K040947 |
| Device Name: | DURASUL BIPOLAR |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | CENTERPULSE ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Audrey Swearingen |
| Correspondent | Audrey Swearingen CENTERPULSE ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-12 |
| Decision Date | 2004-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024365698 | K040947 | 000 |
| 00889024365612 | K040947 | 000 |
| 00889024365605 | K040947 | 000 |
| 00889024365599 | K040947 | 000 |
| 00889024365582 | K040947 | 000 |
| 00889024365575 | K040947 | 000 |
| 00889024365568 | K040947 | 000 |
| 00889024365551 | K040947 | 000 |
| 00889024365544 | K040947 | 000 |
| 00889024365537 | K040947 | 000 |
| 00889024365520 | K040947 | 000 |
| 00889024365513 | K040947 | 000 |
| 00889024365506 | K040947 | 000 |
| 00889024365490 | K040947 | 000 |
| 00889024365483 | K040947 | 000 |
| 00889024365476 | K040947 | 000 |
| 00889024365469 | K040947 | 000 |
| 00889024365452 | K040947 | 000 |
| 00889024365629 | K040947 | 000 |
| 00889024365636 | K040947 | 000 |
| 00889024365681 | K040947 | 000 |
| 00889024365674 | K040947 | 000 |
| 00889024365667 | K040947 | 000 |
| 00889024365650 | K040947 | 000 |
| 00889024365643 | K040947 | 000 |
| 00889024183018 | K040947 | 000 |
| 00889024458093 | K040947 | 000 |
| 00889024458086 | K040947 | 000 |
| 00889024365780 | K040947 | 000 |
| 00889024365773 | K040947 | 000 |
| 00889024365766 | K040947 | 000 |
| 00889024365759 | K040947 | 000 |
| 00889024365742 | K040947 | 000 |
| 00889024365735 | K040947 | 000 |
| 00889024365728 | K040947 | 000 |
| 00889024365711 | K040947 | 000 |
| 00889024365704 | K040947 | 000 |
| 00889024365445 | K040947 | 000 |