Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K200725
Citregen Tendon Interference Screw and Citrelock · Acuitive Technologies · decided 2020-10-07 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CitreLock 7.5mm Reamer | 40-101-1075 | Acuitive Technologies, Inc. | HTO | 00810027270092 |
| 5 x 15mm CitreLock Implant | 30-102-0515 | Acuitive Technologies, Inc. | MAI | 00810027270207 |
| 7 x 15mm CitreLock Xpress Implant Kit | 70-812-0715 | Acuitive Technologies, Inc. | HWC MAI | 00810027270344 |
| CitreLock 8.0mm Reamer | 40-101-1080 | Acuitive Technologies, Inc. | HTO | 00810027270108 |
| 7 x 23mm CitreLock Implant | 30-102-0723 | Acuitive Technologies, Inc. | MAI | 00810027270184 |
| Citregen Tendon Sizing Kit | 70-811-0001 | Acuitive Technologies, Inc. | HWQ HWT HXI | 00810027270283 |
| CitreLock 6.5mm Reamer | 40-101-1065 | Acuitive Technologies, Inc. | HTO | 00810027270078 |
| 4 x 10mm CitreLock Implant | 30-102-0410 | Acuitive Technologies, Inc. | MAI | 00810027270245 |
| 6 x 23mm CitreLock Xpress Implant Kit | 70-812-0623 | Acuitive Technologies, Inc. | HWC MAI | 00810027270337 |
| 8 x 15mm CitreLock Xpress Implant Kit | 70-812-0815 | Acuitive Technologies, Inc. | HWC MAI | 00810027270368 |
| 5 x 15mm CitreLock Xpress Implant Kit | 70-812-0515 | Acuitive Technologies, Inc. | HWC MAI | 00810027270313 |
| 6 x 23mm CitreLock Implant | 30-102-0623 | Acuitive Technologies, Inc. | MAI | 00810027270221 |
| CitreLock Inserter Large | 40-102-0002 | Acuitive Technologies, Inc. | HXG | 00810027270139 |
| 8 x 23mm CitreLock Xpress Implant Kit | 70-812-0823 | Acuitive Technologies, Inc. | HWC MAI | 00810027270375 |
| 5 x 10mm CitreLock Implant | 30-102-0510 | Acuitive Technologies, Inc. | MAI | 00810027270191 |
| CitreLock Sizing Guide | 40-101-0006 | Acuitive Technologies, Inc. | HWT | 00810027270016 |
| CitreLock 2.4mm K-Wire, Trocar Tip | 40-101-0004 | Acuitive Technologies, Inc. | HWQ HXI | 00810027270009 |
| 7 x 23mm CitreLock Xpress Implant Kit | 70-812-0723 | Acuitive Technologies, Inc. | HWC MAI | 00810027270351 |
| CitreLock 5.0mm Reamer | 40-101-1050 | Acuitive Technologies, Inc. | HTO | 00810027270047 |
| CitreLock Tendon Fixation Lid | 40-999-0003 | Acuitive Technologies, Inc. | FSM | 00810027270160 |
| CitreLock Tendon Fixation Tray | 40-898-0003 | Acuitive Technologies, Inc. | FSM | 00810027270146 |
| CitreLock 8.5mm Reamer | 40-101-1085 | Acuitive Technologies, Inc. | HTO | 00810027270115 |
| CitreLock 7.0mm Reamer | 40-101-1070 | Acuitive Technologies, Inc. | HTO | 00810027270085 |
| CitreLock Inserter Small | 40-102-0001 | Acuitive Technologies, Inc. | HXG | 00810027270122 |
| CitreLock Tendon Fixation Kit, Empty | 40-899-0003 | Acuitive Technologies, Inc. | FSM | 00810027270153 |