510(k) Report

Devices descending from K013534

241 later devices reach Self-Countersinking Bone Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+11K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+11K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+11K241846E3D™-C Interbody SystemEvolution Spine20246—
+11K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+11K240368E3D™-A Interbody SystemEvolution Spine20247—
+11K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+11K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+11K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+11K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+11K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+11K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+11K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+11K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+12K262094E3D™-C Interbody SystemEvolution Spine20260—
+12K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+12K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+12K260038E3D™-C Interbody SystemEvolution Spine20261—
+12K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+12K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+12K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+12K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+12K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+12K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+12K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+12K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+12K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+12K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+12K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+12K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+12K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+13K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+13K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+13K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+13K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+13K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+13K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+13K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+13K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+13K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+14K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—