The following data is part of a premarket notification filed by Altatec Gmbh with the FDA for Isy Implant System.
| Device ID | K151599 |
| 510k Number | K151599 |
| Device Name: | ISy Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Altatec GmbH Maybachstrasse 5 Wimsheim, DE D-71299 |
| Contact | Colleen Boswell |
| Correspondent | Linda Schulz PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-12 |
| Decision Date | 2015-10-02 |
| Summary: | summary |