The following data is part of a premarket notification filed by Osseofuse, Inc. with the FDA for One Plus Implant System.
| Device ID | K133050 |
| 510k Number | K133050 |
| Device Name: | ONE PLUS IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | OSSEOFUSE, INC. 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92833 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung OSSEOFUSE, INC. 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92833 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-27 |
| Decision Date | 2014-09-19 |
| Summary: | summary |