The following data is part of a premarket notification filed by Interpore Cross Intl. with the FDA for Interpore Cross International Anterior Fixation Device (afd).
Device ID | K022143 |
510k Number | K022143 |
Device Name: | INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD) |
Classification | Spinal Vertebral Body Replacement Device |
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 | MQP |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-07-02 |
Decision Date | 2003-01-23 |
Summary: | summary |