The following data is part of a premarket notification filed by Interpore Cross Intl. with the FDA for Interpore Cross Cement Restrictor.
| Device ID | K032095 |
| 510k Number | K032095 |
| Device Name: | INTERPORE CROSS CEMENT RESTRICTOR |
| Classification | Prosthesis, Hip, Cement Restrictor |
| 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 | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-08 |
| Decision Date | 2003-08-08 |
| Summary: | summary |