The following data is part of a premarket notification filed by Ldr Spine Usa with the FDA for Facetbridge System.
| Device ID | K152137 |
| 510k Number | K152137 |
| Device Name: | FacetBRIDGE System |
| Classification | System, Facet Screw Spinal Device |
| Applicant | LDR SPINE USA 13785 Research Boulevard, Suite 200 Austin, TX 78750 |
| Contact | James Wilson |
| Correspondent | Jamie E. Wilson LDR SPINE USA 13785 Research Boulevard, Suite 200 Austin, TX 78750 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-31 |
| Decision Date | 2016-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03662663026505 | K152137 | 000 |
| 03662663026390 | K152137 | 000 |
| 03662663026383 | K152137 | 000 |
| 03662663026376 | K152137 | 000 |
| 03662663026369 | K152137 | 000 |
| 03662663026352 | K152137 | 000 |
| 03662663026345 | K152137 | 000 |
| 03662663026338 | K152137 | 000 |
| 03662663026321 | K152137 | 000 |
| 03662663026406 | K152137 | 000 |
| 03662663026413 | K152137 | 000 |
| 03662663026499 | K152137 | 000 |
| 03662663026482 | K152137 | 000 |
| 03662663026475 | K152137 | 000 |
| 03662663026468 | K152137 | 000 |
| 03662663026451 | K152137 | 000 |
| 03662663026444 | K152137 | 000 |
| 03662663026437 | K152137 | 000 |
| 03662663026420 | K152137 | 000 |
| 03662663026314 | K152137 | 000 |