The following data is part of a premarket notification filed by Rhausler, Inc. with the FDA for Rt2 Trabeculite Titanium Cervical Cage System.
| Device ID | K150455 |
| 510k Number | K150455 |
| Device Name: | RT2 Trabeculite Titanium Cervical Cage System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | RHAUSLER, INC. 837 INDUSTRIAL ROAD UNIT E San Carlos, CA 94070 |
| Contact | Terry Johnston |
| Correspondent | Dionicia Reblando DIONICIA REBLANDO 837 Industrial Road, Unit E San Carlos, CA 94070 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-20 |
| Decision Date | 2015-11-19 |
| Summary: | summary |