The following data is part of a premarket notification filed by Medicon, E.g. with the FDA for Medicon Imf-orion Screws.
| Device ID | K050478 |
| 510k Number | K050478 |
| Device Name: | MEDICON IMF-ORION SCREWS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | MEDICON, E.G. GAENSAECKER 15 Tuttlingen, DE D-78532 |
| Contact | Joachim Schmid |
| Correspondent | Joachim Schmid MEDICON, E.G. GAENSAECKER 15 Tuttlingen, DE D-78532 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-24 |
| Decision Date | 2005-06-15 |
| Summary: | summary |