The following data is part of a premarket notification filed by Ldr Spine Usa with the FDA for Ldr Spine Easyspine System.
| Device ID | K082592 |
| 510k Number | K082592 |
| Device Name: | LDR SPINE EASYSPINE SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| 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 | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-08 |
| Decision Date | 2008-10-08 |
| Summary: | summary |