Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K253129
Infinity OCT System · Medtronic Sofamor Danek USA, Inc. · decided 2025-10-24 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| INFINITY™ Occipitocervical Upper Thoracic System | G3650315 | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 00763000993498 |
| INFINITY™ Occipitocervical Upper Thoracic System | 365PT3524 | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 00763000991333 |
| INFINITY™ Occipitocervical Upper Thoracic System | 3654524 | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 00763000991142 |
| INFINITY™ Occipitocervical Upper Thoracic System | G3653508 | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 00763000992514 |
| INFINITY™ Occipitocervical Upper Thoracic System | G365PT4040 | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 00763000992507 |
| INFINITY™ Occipitocervical Upper Thoracic System | 365PT4040 | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 00763000991531 |
| INFINITY™ Occipitocervical Upper Thoracic System | 365PT3520 | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 00763000991319 |
| INFINITY™ Occipitocervical Upper Thoracic System | 365PT3538 | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 00763000991401 |
| INFINITY™ Occipitocervical Upper Thoracic System | G3653540 | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 00763000992675 |
| INFINITY™ Occipitocervical Upper Thoracic System | 3654026 | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 00763000990978 |
| INFINITY™ Occipitocervical Upper Thoracic System | 3654532 | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 00763000991180 |
| INFINITY™ Occipitocervical Upper Thoracic System | 3654528 | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 00763000991166 |
| INFINITY™ Occipitocervical Upper Thoracic System | G365PT4038 | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 00763000992491 |
| INFINITY™ Occipitocervical Upper Thoracic System | G3654534 | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 00763000993009 |
| INFINITY™ Occipitocervical Upper Thoracic System | 3654510 | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 00763000991074 |
| INFINITY™ Occipitocervical Upper Thoracic System | G365PT4036 | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 00763000992484 |
| INFINITY™ Occipitocervical Upper Thoracic System | 3654542 | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 00763000991234 |
| INFINITY™ Occipitocervical Upper Thoracic System | 3654032 | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 00763000991005 |
| INFINITY™ Occipitocervical Upper Thoracic System | 3653516 | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 00763000990749 |
| INFINITY™ Occipitocervical Upper Thoracic System | G3654538 | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 00763000993023 |
| INFINITY™ Occipitocervical Upper Thoracic System | 3653528 | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 00763000990800 |
| INFINITY™ Occipitocervical Upper Thoracic System | 3653542 | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 00763000990879 |
| INFINITY™ Occipitocervical Upper Thoracic System | 3653508 | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 00763000990701 |
| INFINITY™ Occipitocervical Upper Thoracic System | 365PT3540 | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 00763000991418 |
| INFINITY™ Occipitocervical Upper Thoracic System | 365PT3528 | MEDTRONIC SOFAMOR DANEK, INC. | NKG | 00763000991357 |