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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K201367

FlareHawk TiHawk9 Interbody Fusion System · Integrity Implants, Inc. · decided 2020-09-23 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
FlareHawkFHTACS0029TTHighridge Medical, LLCMAX03662663094627
FlareHawkFHPACT0925TTHighridge Medical, LLCMAX03662663094184
FlareHawkFHPACT0925TTIntegrity Implants Inc.MAX00810004728172
FlareHawkFHTACT0929TTHighridge Medical, LLCMAX03662663094726
FlareHawkFHPACS0025TTIntegrity Implants Inc.MAX00810004728158
FlareHawkFHPACS0025TTHighridge Medical, LLCMAX03662663094085
FlareHawkFHTACT0929TTIntegrity Implants Inc.MAX00810004728202
FlareHawkFHPACT0025TTHighridge Medical, LLCMAX03662663094146
FlareHawkFHPACT0025TTIntegrity Implants Inc.MAX00810004728165
FlareHawkFHTACT0029TTHighridge Medical, LLCMAX03662663094689
FlareHawkFHTACS0029TTIntegrity Implants Inc.MAX00810004728189
FlareHawkFHTACT0029TTIntegrity Implants Inc.MAX00810004728196