The following data is part of a premarket notification filed by Interpore Cross Intl. with the FDA for Interpore Cross Anterior Cervical Plate System.
| Device ID | K002592 |
| 510k Number | K002592 |
| Device Name: | INTERPORE CROSS ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Contact | Prosie Rey-fessler |
| Correspondent | Prosie Rey-fessler INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-21 |
| Decision Date | 2000-10-06 |