The following data is part of a premarket notification filed by Altatec Gmbh with the FDA for Isy.
| Device ID | K133991 |
| 510k Number | K133991 |
| Device Name: | ISY |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ALTATEC GMBH 12264 EL CAMINO REAL SUITE 400 San Diego, CA 92130 |
| Contact | Linda Schulz |
| Correspondent | Linda Schulz ALTATEC GMBH 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 | 2013-12-26 |
| Decision Date | 2014-08-06 |
| Summary: | summary |