The following data is part of a premarket notification filed by Interpore Cross Intl. with the FDA for Interpore Cross International Anterior Fixation Device (afd).
| Device ID | K022143 |
| 510k Number | K022143 |
| Device Name: | INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD) |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Contact | Lynn M Rodarti |
| Correspondent | Lynn M Rodarti INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-02 |
| Decision Date | 2003-01-23 |
| Summary: | summary |