The following data is part of a premarket notification filed by Interpore Cross Intl. with the FDA for Titanium Mesh Implant.
Device ID | K041407 |
510k Number | K041407 |
Device Name: | TITANIUM MESH IMPLANT |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-05-27 |
Decision Date | 2004-12-29 |
Summary: | summary |