The following data is part of a premarket notification filed by Ldr Spine Usa Inc. with the FDA for Ldr Spine Spinetune Tl Spinal System.
| Device ID | K120760 |
| 510k Number | K120760 |
| Device Name: | LDR SPINE SPINETUNE TL SPINAL SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | LDR SPINE USA INC. 13785 RESEARCH BOULEVARD SUITE 200 Austin, TX 78750 |
| Contact | Kiersten Soderman |
| Correspondent | Kiersten Soderman LDR SPINE USA INC. 13785 RESEARCH BOULEVARD SUITE 200 Austin, TX 78750 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-13 |
| Decision Date | 2012-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03662663007870 | K120760 | 000 |
| 03662663006972 | K120760 | 000 |
| 03662663006965 | K120760 | 000 |
| 03662663006958 | K120760 | 000 |
| 03662663006941 | K120760 | 000 |
| 03662663006934 | K120760 | 000 |
| 03662663006927 | K120760 | 000 |
| 03662663006910 | K120760 | 000 |
| 03662663006903 | K120760 | 000 |
| 03662663006897 | K120760 | 000 |
| 03662663006989 | K120760 | 000 |
| 03662663006996 | K120760 | 000 |
| 03662663007863 | K120760 | 000 |
| 03662663007856 | K120760 | 000 |
| 03662663007061 | K120760 | 000 |
| 03662663007054 | K120760 | 000 |
| 03662663007047 | K120760 | 000 |
| 03662663007030 | K120760 | 000 |
| 03662663007023 | K120760 | 000 |
| 03662663007016 | K120760 | 000 |
| 03662663007009 | K120760 | 000 |
| 03662663006880 | K120760 | 000 |