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FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11
Categories8
Latest FDA decision2025-12-11
TypeNumberDevice NameCodeDateActions
510(k) K253200 Cervical Spine Truss System - Stand Alone (CSTS-SA)OVE2025-12-11 View
510(k) K240388 Osteotomy Truss System (OTS)HRS2024-11-01 View
510(k) K233966 Anterior Spine Truss System-Stand Alone (ASTS-SA)OVD2024-04-22 View
510(k) K230088 Ankle Truss System (ATS)SAI2024-03-21 View
510(k) K231739 Cervical Spine Truss System (CSTS)OVE2023-09-25 View
510(k) K223362 Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion DeviceOVE2023-02-02 View
510(k) K221266 Cervical Spine Truss System (CSTS) Interbody Fusion DeviceODP2023-01-05 View
510(k) K221283 Hammertoe Truss System (HTS)HTY2022-09-06 View
510(k) K220463 Osteotomy Truss System (OTS)HRS2022-05-18 View
510(k) K212527 Cervical Spine Truss System Plating Solution (CSTS-PS)KWQ2022-05-17 View
510(k) K211388 Lateral Spine Truss System (LSTS) Interbody Fusion DeviceMAX2021-08-05 View
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