The following data is part of a premarket notification filed by Ldr Spine Usa with the FDA for Ldr Spine Usa C-plate, Tl Anterior Cervical Plate System.
| Device ID | K102265 |
| 510k Number | K102265 |
| Device Name: | LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | LDR SPINE USA 4030 WEST BRAKER LANE SUITE 360 Austin, TX 78759 |
| Contact | Beckinam Nowatzke |
| Correspondent | Beckinam Nowatzke LDR SPINE USA 4030 WEST BRAKER LANE SUITE 360 Austin, TX 78759 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-10 |
| Decision Date | 2010-09-29 |
| Summary: | summary |