The following data is part of a premarket notification filed by Ldr Spine Usa with the FDA for Ldr Spine Easyspine Posterior Osteosynthesis System.
| Device ID | K070341 |
| 510k Number | K070341 |
| Device Name: | LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | LDR SPINE USA 4030 WEST BRAKER LANE SUITE 360 Austin, TX 78759 |
| Contact | James Burrows |
| Correspondent | James Burrows LDR SPINE USA 4030 WEST BRAKER LANE SUITE 360 Austin, TX 78759 |
| Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | NKB |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-06 |
| Decision Date | 2007-08-08 |
| Summary: | summary |