The following data is part of a premarket notification filed by Interpore Cross Intl. with the FDA for Peek Cas.
| Device ID | K050861 |
| 510k Number | K050861 |
| Device Name: | PEEK CAS |
| Classification | Spinal Vertebral Body Replacement Device |
| 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 | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-05 |
| Decision Date | 2005-05-27 |
| Summary: | summary |