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

Clearance record K182684

HammerTechTM Fixation System · Fusion Orthopedics, LLC · decided 2018-11-23 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
HammerTech HT-60-1010-SFUSION ORTHOPEDICS, LLCHWC00852164007971
HammerTechCD-2X-1045FUSION ORTHOPEDICS, LLCLRY00840124511866
HammerTech CD-01-6024FUSION ORTHOPEDICS, LLCHWC00819034027156
HammerTech TN-03-1120FUSION ORTHOPEDICS, LLCHWC00819034027101
HammerTechHT-2X-4526FUSION ORTHOPEDICS, LLCHWC00840124512177
HammerTech HT-TM-6650FUSION ORTHOPEDICS, LLCHWC00852164007339
HammerTech HT-KW-4010FUSION ORTHOPEDICS, LLCHWC00819034027569
HammerTechHT-2X-4512FUSION ORTHOPEDICS, LLCHWC00840124512108
HammerTech HT-60-0808-SFUSION ORTHOPEDICS, LLCHWC00852164007964
HammerTech HT-10-1130FUSION ORTHOPEDICS, LLCHWC00852164007384
HammerTechHT-2X-3426FUSION ORTHOPEDICS, LLCHWC00840124512047
HammerTechHT-2X-4522FUSION ORTHOPEDICS, LLCHWC00840124512153
HammerTechCD-01-6127FUSION ORTHOPEDICS, LLCHWC00840124508149
HammerTech HT-TM-5550-SFUSION ORTHOPEDICS, LLCHWC00852164007452
HammerTech HT-TM-5540-S1FUSION ORTHOPEDICS, LLCHWC00852164007698
HammerTech CD-HT-6650-SFUSION ORTHOPEDICS, LLCHWC00852164007605
HammerTech HT-TM-6610-SFUSION ORTHOPEDICS, LLCHWC00852164007469
HammerTech HT-10-1110-S1FUSION ORTHOPEDICS, LLCHWC00852164007803
HammerTech HT-KW-4014FUSION ORTHOPEDICS, LLCHWC00819034027576
HammerTech HT-10-1150-S1FUSION ORTHOPEDICS, LLCHWC00852164007858
HammerTech HT-TM-5510-SFUSION ORTHOPEDICS, LLCHWC00852164007414
HammerTechHT-2X-3422FUSION ORTHOPEDICS, LLCHWC00840124512023
HammerTech HT-10-1140FUSION ORTHOPEDICS, LLCHWC00852164007391
HammerTechCD-2X-1026FUSION ORTHOPEDICS, LLCLRY00840124511842
HammerTechTN-2X-3045FUSION ORTHOPEDICS, LLCHWR00840124511835