The following data is part of a premarket notification filed by Ldr Spine Usa with the FDA for Ldr Spine Roi-c Implant.
| Device ID | K083857 |
| 510k Number | K083857 |
| Device Name: | LDR SPINE ROI-C IMPLANT |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | LDR SPINE USA 4030 WEST BRAKER LANE SUITE 360 Austin, TX 78759 |
| Contact | Noah Bartsch |
| Correspondent | Noah Bartsch LDR SPINE USA 4030 WEST BRAKER LANE SUITE 360 Austin, TX 78759 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-24 |
| Decision Date | 2009-02-12 |
| Summary: | summary |