The following data is part of a premarket notification filed by Ldr Spine Usa with the FDA for Modification To Easyspine System.
| Device ID | K063794 |
| 510k Number | K063794 |
| Device Name: | MODIFICATION TO EASYSPINE SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | LDR SPINE USA 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Contact | Floyd G Larson |
| Correspondent | Floyd G Larson LDR SPINE USA 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-22 |
| Decision Date | 2007-01-24 |
| Summary: | summary |