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)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| HammerTech | HT-60-1010-S | FUSION ORTHOPEDICS, LLC | HWC | 00852164007971 |
| HammerTech | CD-2X-1045 | FUSION ORTHOPEDICS, LLC | LRY | 00840124511866 |
| HammerTech | CD-01-6024 | FUSION ORTHOPEDICS, LLC | HWC | 00819034027156 |
| HammerTech | TN-03-1120 | FUSION ORTHOPEDICS, LLC | HWC | 00819034027101 |
| HammerTech | HT-2X-4526 | FUSION ORTHOPEDICS, LLC | HWC | 00840124512177 |
| HammerTech | HT-TM-6650 | FUSION ORTHOPEDICS, LLC | HWC | 00852164007339 |
| HammerTech | HT-KW-4010 | FUSION ORTHOPEDICS, LLC | HWC | 00819034027569 |
| HammerTech | HT-2X-4512 | FUSION ORTHOPEDICS, LLC | HWC | 00840124512108 |
| HammerTech | HT-60-0808-S | FUSION ORTHOPEDICS, LLC | HWC | 00852164007964 |
| HammerTech | HT-10-1130 | FUSION ORTHOPEDICS, LLC | HWC | 00852164007384 |
| HammerTech | HT-2X-3426 | FUSION ORTHOPEDICS, LLC | HWC | 00840124512047 |
| HammerTech | HT-2X-4522 | FUSION ORTHOPEDICS, LLC | HWC | 00840124512153 |
| HammerTech | CD-01-6127 | FUSION ORTHOPEDICS, LLC | HWC | 00840124508149 |
| HammerTech | HT-TM-5550-S | FUSION ORTHOPEDICS, LLC | HWC | 00852164007452 |
| HammerTech | HT-TM-5540-S1 | FUSION ORTHOPEDICS, LLC | HWC | 00852164007698 |
| HammerTech | CD-HT-6650-S | FUSION ORTHOPEDICS, LLC | HWC | 00852164007605 |
| HammerTech | HT-TM-6610-S | FUSION ORTHOPEDICS, LLC | HWC | 00852164007469 |
| HammerTech | HT-10-1110-S1 | FUSION ORTHOPEDICS, LLC | HWC | 00852164007803 |
| HammerTech | HT-KW-4014 | FUSION ORTHOPEDICS, LLC | HWC | 00819034027576 |
| HammerTech | HT-10-1150-S1 | FUSION ORTHOPEDICS, LLC | HWC | 00852164007858 |
| HammerTech | HT-TM-5510-S | FUSION ORTHOPEDICS, LLC | HWC | 00852164007414 |
| HammerTech | HT-2X-3422 | FUSION ORTHOPEDICS, LLC | HWC | 00840124512023 |
| HammerTech | HT-10-1140 | FUSION ORTHOPEDICS, LLC | HWC | 00852164007391 |
| HammerTech | CD-2X-1026 | FUSION ORTHOPEDICS, LLC | LRY | 00840124511842 |
| HammerTech | TN-2X-3045 | FUSION ORTHOPEDICS, LLC | HWR | 00840124511835 |