The following data is part of a premarket notification filed by Interpore Intl. with the FDA for Interpore Imz Cylinder Implant System.
| Device ID | K913228 |
| 510k Number | K913228 |
| Device Name: | INTERPORE IMZ CYLINDER IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | INTERPORE INTL. 18008 SKYPARK CIRCLE Irvine, CA 92714 |
| Contact | Eve A Conner |
| Correspondent | Eve A Conner INTERPORE INTL. 18008 SKYPARK CIRCLE Irvine, CA 92714 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-22 |
| Decision Date | 1992-10-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841307118725 | K913228 | 000 |