Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K210595
SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers · Camber Spine Technologies, LLC · decided 2021-06-15 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| SPIRA®-T Integrated Fixation System | SPT-3211-0714 | CAMBER SPINE TECHNOLOGIES, LLC | MAX | B030SPT321107140 |
| SPIRA®-T Integrated Fixation System | SPT-2811-1511 | CAMBER SPINE TECHNOLOGIES, LLC | MAX | B030SPT281115110 |
| SPIRA®-T Integrated Fixation System | SPT-2609-0708 | CAMBER SPINE TECHNOLOGIES, LLC | MAX | B030SPT260907080 |
| SPIRA®-P Integrated Fixation System | SPP-3010-0713 | CAMBER SPINE TECHNOLOGIES, LLC | MAX | B030SPP301007130 |
| SPIRA®-P Integrated Fixation System | SPP-2212-1511 | CAMBER SPINE TECHNOLOGIES, LLC | MAX | B030SPP221215110 |
| SPIRA®-T Integrated Fixation System | SPT-3209-0714 | CAMBER SPINE TECHNOLOGIES, LLC | MAX | B030SPT320907140 |
| SPIRA®-T Integrated Fixation System | SPT-2809-0713 | CAMBER SPINE TECHNOLOGIES, LLC | MAX | B030SPT280907130 |
| SPIRA®-P Integrated Fixation System | SPP-3412-0714 | CAMBER SPINE TECHNOLOGIES, LLC | MAX | B030SPP341207140 |
| SPIRA®-P Integrated Fixation System | SPP-2612-0717 | CAMBER SPINE TECHNOLOGIES, LLC | MAX | B030SPP261207170 |
| SPIRA®-T Integrated Fixation System | SPT-3411-0711 | CAMBER SPINE TECHNOLOGIES, LLC | MAX | B030SPT341107110 |
| SPIRA®-T Integrated Fixation System | SPT-2211-0707 | CAMBER SPINE TECHNOLOGIES, LLC | MAX | B030SPT221107070 |
| SPIRA®-P Integrated Fixation System | SPP-3212-0718 | CAMBER SPINE TECHNOLOGIES, LLC | MAX | B030SPP321207180 |
| SPIRA®-T Integrated Fixation System | SPT-3011-0717 | CAMBER SPINE TECHNOLOGIES, LLC | MAX | B030SPT301107170 |
| SPIRA®-P Integrated Fixation System | SPP-3410-1510 | CAMBER SPINE TECHNOLOGIES, LLC | MAX | B030SPP341015100 |
| SPIRA®-T Integrated Fixation System | SPT-2809-0709 | CAMBER SPINE TECHNOLOGIES, LLC | MAX | B030SPT280907090 |
| SPIRA®-T Integrated Fixation System | SPT-3411-0715 | CAMBER SPINE TECHNOLOGIES, LLC | MAX | B030SPT341107150 |
| SPIRA®-T Integrated Fixation System | SPT-3211-0709 | CAMBER SPINE TECHNOLOGIES, LLC | MAX | B030SPT321107090 |
| SPIRA®-T Integrated Fixation System | SPT-3209-1513 | CAMBER SPINE TECHNOLOGIES, LLC | MAX | B030SPT320915130 |
| SPIRA®-T Integrated Fixation System | SPT-3011-1513 | CAMBER SPINE TECHNOLOGIES, LLC | MAX | B030SPT301115130 |
| SPIRA®-T Integrated Fixation System | SPT-2809-0715 | CAMBER SPINE TECHNOLOGIES, LLC | MAX | B030SPT280907150 |
| SPIRA®-P Integrated Fixation System | SPP-2210-1511 | CAMBER SPINE TECHNOLOGIES, LLC | MAX | B030SPP221015110 |
| SPIRA®-P Integrated Fixation System | SPP-2210-1510 | CAMBER SPINE TECHNOLOGIES, LLC | MAX | B030SPP221015100 |
| SPIRA®-P Integrated Fixation System | SPP-2210-1509 | CAMBER SPINE TECHNOLOGIES, LLC | MAX | B030SPP221015090 |
| SPIRA®-T Integrated Fixation System | SPT-3411-1514 | CAMBER SPINE TECHNOLOGIES, LLC | MAX | B030SPT341115140 |
| SPIRA®-T Integrated Fixation System | SPT-2811-0710 | CAMBER SPINE TECHNOLOGIES, LLC | MAX | B030SPT281107100 |