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

Total Devices11
Categories7
Latest FDA decision2026-02-12
TypeNumberDevice NameCodeDateActions
510(k) K253201 Lumbar Spine Truss System - Plating Solution (LSTS-PS)KWQ2026-02-12 View
510(k) K203065 Lumbar Spine Truss System Plating Solution (LSTS-PS)KWQ2021-03-10 View
510(k) K200002 Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion DeviceOVD2020-05-29 View
510(k) K190870 Cervical Spinal Truss System-Stand Alone (CSTS-SA)OVE2019-08-12 View
510(k) K190926 Hammertoe Truss System (HTS)HTY2019-07-23 View
510(k) K172294 Osteotomy Truss System (OTS)HRS2018-02-22 View
510(k) K173159 Cervical Spinal Truss System (CSTS) Interbody Fusion DeviceODP2018-01-08 View
510(k) K172392 Lateral Spinal Truss System (LSTS) Interbody Fusion DeviceMAX2017-11-07 View
510(k) K171351 Posterior Spine Truss System (PSTS) Interbody Fusion DeviceMAX2017-09-08 View
510(k) K170851 Anterior Spine Truss System (STS) Interbody Fusion DeviceMAX2017-08-07 View
510(k) K153436 LATERAL Spine Truss SystemMAX2016-06-06 View