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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)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
SacroFuse01-42300-55SPINEFRONTIER, INC.OUR00190361036074
SacroFuse14-42001SPINEFRONTIER, INC.HWR00190361023272
SacroFuse01-42404-80SPINEFRONTIER, INC.OUR00190361029540
SacroFuse01-42404-30SPINEFRONTIER, INC.OUR00190361029526
SacroFuse01-42301-40SPINEFRONTIER, INC.OUR00190361036135
SacroFuse01-42400-35SPINEFRONTIER, INC.OUR00190361023296
SacroFuse01-42202-45SPINEFRONTIER, INC.OUR00190361035886
SacroFuse01-42404-120SPINEFRONTIER, INC.OUR00190361029588
SacroFuse01-42400-40SPINEFRONTIER, INC.OUR00190361023302
SacroFuse01-42400-90SPINEFRONTIER, INC.OUR00190361029410
SacroFuse01-42405-40SPINEFRONTIER, INC.OUR00190361029250
SacroFuse01-42403-70SPINEFRONTIER, INC.OUR00190361023623
SacroFuse01-42401-50SPINEFRONTIER, INC.OUR00190361023418
SacroFuse01-42202-65SPINEFRONTIER, INC.OUR00190361035916
SacroFuse01-42400-55SPINEFRONTIER, INC.OUR00190361023333
SacroFuse01-42300-45SPINEFRONTIER, INC.OUR00190361036050
SacroFuse01-42401-35SPINEFRONTIER, INC.OUR00190361023388
SacroFuse01-42202-50SPINEFRONTIER, INC.OUR00190361035862
SacroFuse01-42403-40SPINEFRONTIER, INC.OUR00190361023562
SacroFuse01-42400-70SPINEFRONTIER, INC.OUR00190361023364
SacroFuse01-42405-60SPINEFRONTIER, INC.OUR00190361029298
SacroFuse01-42404-65SPINEFRONTIER, INC.OUR00190361029236
SacroFuse01-42400-60SPINEFRONTIER, INC.OUR00190361023340
SacroFuse01-42404-45SPINEFRONTIER, INC.OUR00190361029199
SacroFuse01-42300-50SPINEFRONTIER, INC.OUR00190361036067