510(k) Report

Devices descending from K945700

692 later devices reach Synthes (Usa) Anterior Cervical Vertebrae Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K201287Impulse Interbody Fusion SystemDegen Medical20208—
+8K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+8K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+8K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+8K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+8K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+8K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+8K182182YUKON OCT Spinal SystemK2m20185—
+8K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+8K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+8K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+8K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+8K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+9K263049SABER-C SystemElevation Spine20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K262094E3D™-C Interbody SystemEvolution Spine20260—
+9K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+9K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+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—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage 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—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+9K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+9K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+9K242042TriALTIS™ Spine SystemMedos International SARL20241—
+9K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+9K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+9K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+9K240368E3D™-A Interbody SystemEvolution Spine20247—
+9K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+9K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+9K232432E3D™-A Interbody SystemEvolution Spine20248—
+9K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+9K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+9K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+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—
+9K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+9K222789VADER® Pedicle System, G21 CementIcotec AG202352
+9K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+9K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+9K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+9K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+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—
+10K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+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—
+10K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+10K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+10K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+10K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+10K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+10K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+10K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+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—