The following data is part of a premarket notification filed by Interpore Intl. with the FDA for Imz Intramobile Cylinder Implant.
| Device ID | K855032 |
| 510k Number | K855032 |
| Device Name: | IMZ INTRAMOBILE CYLINDER IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| 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 | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-16 |
| Decision Date | 1986-03-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841307118749 | K855032 | 000 |
| 10841307118732 | K855032 | 000 |
| 10841307118657 | K855032 | 000 |
| 10841307117971 | K855032 | 000 |