The following data is part of a premarket notification filed by Idi Biomedical Llc with the FDA for Idi Implant System.
| Device ID | K081806 |
| 510k Number | K081806 |
| Device Name: | IDI IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | IDI BIOMEDICAL LLC 104 2ND ST. SE Catawba, NC 28609 |
| Contact | Angela Blackwell |
| Correspondent | Angela Blackwell IDI BIOMEDICAL LLC 104 2ND ST. SE Catawba, NC 28609 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-26 |
| Decision Date | 2008-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D747IDI1035105A1 | K081806 | 000 |
| D747IDI1035088A1 | K081806 | 000 |