510(k) Report

Devices descending from K012945

711 later devices reach Synthes 2.4 MM Cannulated Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+11K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+11K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+11K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+11K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+11K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+12K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+12K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+12K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+12K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+12K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—