The following data is part of a premarket notification filed by Ldr Spine Usa with the FDA for Modification To Ldr Spine Roi Interbody Fusion System; Roi-a Implant System.
| Device ID | K090507 |
| 510k Number | K090507 |
| Device Name: | MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| 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 | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-25 |
| Decision Date | 2009-06-25 |
| Summary: | summary |