Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K220195
iFuse Bedrock Granite Implant System · SI-BONE, Inc. · decided 2022-05-26 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| iFuse Granite Implant System | 115105BG | Si-Bone Inc. | OUR | 00810055521593 |
| iFuse Granite Implant System | 400271 | Si-Bone Inc. | LXH | 00810055520794 |
| iFuse Granite Implant System | 501350 | Si-Bone Inc. | LXH | 00810055521067 |
| iFuse Granite Implant System | 400279 | Si-Bone Inc. | LXH | 00810055520862 |
| iFuse Granite Implant System | 400276 | Si-Bone Inc. | LXH | 00810055520848 |
| iFuse Granite Implant System | 105090BG | Si-Bone Inc. | OUR | 00810055521401 |
| iFuse Granite Implant System | 115110BG | Si-Bone Inc. | OUR | 00810055521609 |
| iFuse Granite Implant System | 400264 | Si-Bone Inc. | LXH | 00810055520756 |
| iFuse Granite Implant System | 400298-0850 | Si-Bone Inc. | LXH | 00810055521135 |
| iFuse Granite Implant System | 400270 | Si-Bone Inc. | LXH | 00810055520787 |
| iFuse Bedrock Granite Implant System | 501859-0900 | Si-Bone Inc. | LXH | 00810055523399 |
| iFuse Bedrock Granite Implant System | 501858-1150 | Si-Bone Inc. | LXH | 00810055523351 |
| iFuse Granite Implant System | 125080BG | Si-Bone Inc. | OUR | 00810055521708 |
| iFuse Granite Implant System | 400281 | Si-Bone Inc. | LXH | 00810055520886 |
| iFuse Granite Implant System | 400302-1100 | Si-Bone Inc. | LXH | 00810055521289 |
| iFuse Granite Implant System | 115065BG | Si-Bone Inc. | OUR | 00810055521517 |
| iFuse Granite Implant System | 105095BG | Si-Bone Inc. | OUR | 00810055521418 |
| iFuse Granite Implant System | 400302-1150 | Si-Bone Inc. | LXH | 00810055520961 |
| iFuse Bedrock Granite Implant System | 501858-1050 | Si-Bone Inc. | LXH | 00810055523337 |
| iFuse Granite Implant System | 400268 | Si-Bone Inc. | LXH | 00810055520763 |
| iFuse Granite Implant System | 125105BG | Si-Bone Inc. | OUR | 00810055521753 |
| iFuse Granite Implant System | 125090BG | Si-Bone Inc. | OUR | 00810055521722 |
| iFuse Granite Implant System | 115120BG | Si-Bone Inc. | OUR | 00810055521623 |
| iFuse Granite Implant System | 400298-0950 | Si-Bone Inc. | LXH | 00810055520909 |
| iFuse Granite Implant System | 501117 | Si-Bone Inc. | NKB | 00810055522088 |