The following data is part of a premarket notification filed by Ldr Spine Usa with the FDA for Easyspine System.
| Device ID | K043094 |
| 510k Number | K043094 |
| Device Name: | EASYSPINE SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | LDR SPINE USA 4030 WEST BRAKER LANE SUITE 360 Austin, TX 78759 |
| Contact | Brian Burkinshaw |
| Correspondent | Brian Burkinshaw LDR SPINE USA 4030 WEST BRAKER LANE SUITE 360 Austin, TX 78759 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-09 |
| Decision Date | 2005-02-11 |
| Summary: | summary |