510(k) Report

Devices descending from K962823

836 later devices reach Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+10K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+10K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+10K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—
+10K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+10K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+10K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+10K240368E3D™-A Interbody SystemEvolution Spine20247—
+10K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+10K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+10K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+10K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+10K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+10K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+10K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+10K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220—
+10K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20211—
+11K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+11K252961Fusion FibFix NailFusion Orthopedics USA, LLC20260—
+11K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+11K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+11K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+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—