510(k) Report

Devices descending from K926453

759 later devices reach Synthes (U.S.a.) Anterior Cervical Vertebrae Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+9K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+9K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+9K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+9K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+9K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+9K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+9K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+9K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+9K242042TriALTIS™ Spine SystemMedos International SARL20241—
+9K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+9K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+9K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+9K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+9K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+9K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+9K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+9K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+9K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+9K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+9K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+9K223418DeGen Impulse AM™ SystemDegen Medical20236—
+9K222789VADER® Pedicle System, G21 CementIcotec AG202352
+9K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+9K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+9K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+9K213417Ghost Spacer SystemLife Spine, Inc.20220—
+9K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+9K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+9K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+9K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+9K200896Solstice CCILife Spine, Inc.20200—
+9K193129Yukon OCT Spinal SystemK2m, Inc.202001
+9K183381Navigation Enabled InstrumentsStryker20191—
+10K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K261279DeltaNEC Interbody SystemNexus Spine20260—
+10K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+10K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+10K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+10K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+10K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+10K232628VADER® Pedicle SystemIcotec AG20241—
+10K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+10K221172FOCUS Interbody SystemOc Medical Devices20220—
+10K201006K2M Navigation InstrumentsK2m, Inc.20200—
+11K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—