Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K141106
FRONTIER DEVICES FUSIO SCREW FUZE SYSTEM · Folsom Metal Products, Inc. Dba Frontier Devices · decided 2014-10-10 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| SiCure Sacroiliac Joint Fusion System | 900.095.35 | ALEVIO, LLC | OUR | B436900095350 |
| SiCure Sacroiliac Joint Fusion System | 900.11.60 | ALEVIO, LLC | OUR | B43690011600 |
| SiCure Sacroiliac Joint Fusion System | 900.11.35 | ALEVIO, LLC | OUR | B43690011350 |
| SiCure Sacroiliac Joint Fusion System | 900.11.40 | ALEVIO, LLC | OUR | B43690011400 |
| SiCure Sacroiliac Joint Fusion System | 900.11 | ALEVIO, LLC | OUR | B436900110 |
| SiCure Sacroiliac Joint Fusion System | 900.095.60 | ALEVIO, LLC | OUR | B436900095600 |
| SiCure Sacroiliac Joint Fusion System | 900.095.40 | ALEVIO, LLC | OUR | B436900095400 |
| SiCure Sacroiliac Joint Fusion System | 900.11.45 | ALEVIO, LLC | OUR | B43690011450 |
| SiCure Sacroiliac Joint Fusion System | 900.095.45 | ALEVIO, LLC | OUR | B436900095450 |
| SiCure Sacroiliac Joint Fusion System | 900.095.55 | ALEVIO, LLC | OUR | B436900095550 |
| SiCure Sacroiliac Joint Fusion System | 900.11.50 | ALEVIO, LLC | OUR | B43690011500 |
| SiCure Sacroiliac Joint Fusion System | 900.095 | ALEVIO, LLC | OUR | B4369000950 |
| SiCure Sacroiliac Joint Fusion System | 900.095.50 | ALEVIO, LLC | OUR | B436900095500 |
| SiCure Sacroiliac Joint Fusion System | 900.11.55 | ALEVIO, LLC | OUR | B43690011550 |