The following data is part of a premarket notification filed by Ldr Spine Usa with the FDA for Ldr Spine Roi Interbody Fusion System.
| Device ID | K082262 |
| 510k Number | K082262 |
| Device Name: | LDR SPINE ROI INTERBODY FUSION SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | LDR SPINE USA 4030 WEST BRAKER LANE SUITE 360 Austin, TX 78759 |
| Contact | Noel Bartsch |
| Correspondent | Noel 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-08 |
| Decision Date | 2009-02-02 |
| Summary: | summary |