The following data is part of a premarket notification filed by Interpore Intl. with the FDA for Imz Intramobile Cylinder Implant System Components.
| Device ID | K870331 |
| 510k Number | K870331 |
| Device Name: | IMZ INTRAMOBILE CYLINDER IMPLANT SYSTEM COMPONENTS |
| Classification | Attachment, Precision, All |
| Applicant | INTERPORE INTL. 18008 SKYPARK CIRCLE Irvine, CA 92714 |
| Contact | Jo Stegwell |
| Correspondent | Jo Stegwell INTERPORE INTL. 18008 SKYPARK CIRCLE Irvine, CA 92714 |
| Product Code | EGG |
| CFR Regulation Number | 872.3165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-28 |
| Decision Date | 1987-03-02 |