510(k) K163375 · NKG Posterior Cervical Screw System
INFINITY OCT System
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Aug 21, 2017 |
| Received | Dec 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163375
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 19, 2023 | Medtronic Sofamor Danek USA Inc INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following a Open, Classified |
KWP | None listed |
| Apr 19, 2023 | Medtronic Sofamor Danek USA Inc INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm, REF 3604532; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following a Open, Classified |
KWP | None listed |
| Apr 19, 2023 | Medtronic Sofamor Danek USA Inc INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0mm x 22mm, REF 360PT4022; for immobilization and stabilization of spinal segment as an adjunct to fusio Open, Classified |
KWP | None listed |
| Apr 19, 2023 | Medtronic Sofamor Danek USA Inc INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm, REF 3604026; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following a Open, Classified |
KWP | None listed |
| Apr 19, 2023 | Medtronic Sofamor Danek USA Inc INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, REF 3604034; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following a Open, Classified |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.