The following data is part of a premarket notification filed by Ldr Spine Usa with the FDA for Ldr Spine Usa Spinetune Tl Spinal System.
| Device ID | K102331 |
| 510k Number | K102331 |
| Device Name: | LDR SPINE USA SPINETUNE TL SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| 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 | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-17 |
| Decision Date | 2010-10-15 |
| Summary: | summary |