Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K150017
SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System · Spinefrontier, Inc. · decided 2015-04-24 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| SacroFuse | 01-42300-55 | SPINEFRONTIER, INC. | OUR | 00190361036074 |
| SacroFuse | 14-42001 | SPINEFRONTIER, INC. | HWR | 00190361023272 |
| SacroFuse | 01-42404-80 | SPINEFRONTIER, INC. | OUR | 00190361029540 |
| SacroFuse | 01-42404-30 | SPINEFRONTIER, INC. | OUR | 00190361029526 |
| SacroFuse | 01-42301-40 | SPINEFRONTIER, INC. | OUR | 00190361036135 |
| SacroFuse | 01-42400-35 | SPINEFRONTIER, INC. | OUR | 00190361023296 |
| SacroFuse | 01-42202-45 | SPINEFRONTIER, INC. | OUR | 00190361035886 |
| SacroFuse | 01-42404-120 | SPINEFRONTIER, INC. | OUR | 00190361029588 |
| SacroFuse | 01-42400-40 | SPINEFRONTIER, INC. | OUR | 00190361023302 |
| SacroFuse | 01-42400-90 | SPINEFRONTIER, INC. | OUR | 00190361029410 |
| SacroFuse | 01-42405-40 | SPINEFRONTIER, INC. | OUR | 00190361029250 |
| SacroFuse | 01-42403-70 | SPINEFRONTIER, INC. | OUR | 00190361023623 |
| SacroFuse | 01-42401-50 | SPINEFRONTIER, INC. | OUR | 00190361023418 |
| SacroFuse | 01-42202-65 | SPINEFRONTIER, INC. | OUR | 00190361035916 |
| SacroFuse | 01-42400-55 | SPINEFRONTIER, INC. | OUR | 00190361023333 |
| SacroFuse | 01-42300-45 | SPINEFRONTIER, INC. | OUR | 00190361036050 |
| SacroFuse | 01-42401-35 | SPINEFRONTIER, INC. | OUR | 00190361023388 |
| SacroFuse | 01-42202-50 | SPINEFRONTIER, INC. | OUR | 00190361035862 |
| SacroFuse | 01-42403-40 | SPINEFRONTIER, INC. | OUR | 00190361023562 |
| SacroFuse | 01-42400-70 | SPINEFRONTIER, INC. | OUR | 00190361023364 |
| SacroFuse | 01-42405-60 | SPINEFRONTIER, INC. | OUR | 00190361029298 |
| SacroFuse | 01-42404-65 | SPINEFRONTIER, INC. | OUR | 00190361029236 |
| SacroFuse | 01-42400-60 | SPINEFRONTIER, INC. | OUR | 00190361023340 |
| SacroFuse | 01-42404-45 | SPINEFRONTIER, INC. | OUR | 00190361029199 |
| SacroFuse | 01-42300-50 | SPINEFRONTIER, INC. | OUR | 00190361036067 |