The following data is part of a premarket notification filed by Ldr Spine Usa with the FDA for Open Radiotransparent Intersomatic Implant (roi).
| Device ID | K043349 |
| 510k Number | K043349 |
| Device Name: | OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI) |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | LDR SPINE USA 4030 WEST BRAKER LANE SUITE 360 Austin, TX 78759 |
| Contact | Brain Burkinshaw |
| Correspondent | Brain Burkinshaw 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-06 |
| Decision Date | 2005-06-29 |
| Summary: | summary |