The following data is part of a premarket notification filed by Ldr Spine Usa with the FDA for Ldr Spine Roi-c Cervical Cage System.
| Device ID | K150765 |
| 510k Number | K150765 |
| Device Name: | LDR Spine ROI-C Cervical Cage System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | LDR SPINE USA 13785 Research Boulevard, Suite 200 Austin, TX 78750 |
| Contact | Brad Strasser |
| Correspondent | Brad Strasser LDR SPINE USA 13785 Research Boulevard, Suite 200 Austin, TX 78750 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-24 |
| Decision Date | 2015-09-17 |
| Summary: | summary |