The following data is part of a premarket notification filed by Interpore Cross Intl. with the FDA for Interpore Cross International (ici) Occipito-cervico-thoracic (oct) Rod And Plate System.
| Device ID | K022048 |
| 510k Number | K022048 |
| Device Name: | INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| 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 | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-24 |
| Decision Date | 2002-12-04 |
| Summary: | summary |