The following data is part of a premarket notification filed by Interpore Cross Intl. with the FDA for C-tek C-trun Anterior Cervical Plate System.
| Device ID | K042798 |
| 510k Number | K042798 |
| Device Name: | C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Contact | Wendy Spielberger |
| Correspondent | Wendy Spielberger INTERPORE CROSS INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-08 |
| Decision Date | 2004-11-04 |
| Summary: | summary |