510(k) Report

Devices descending from K101301

474 later devices reach Stalif Midline through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+5K200316UNiD IB3D ALIFMedicrea International SA20200—
+5K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+5K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+5K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+5K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+5K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+5K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+5K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+5K191066CD Horizon™ Astute™ Spinal SystemMedtronic Sofamor Danek USA, Inc.201921—
+5K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+5K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+5K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+5K183243Velofix TLIF CageU&I Corporation20190—
+5K190959ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with…Medtronic Sofamor Danek USA, Inc.2019108—
+5K183397ChoiceSpine Stealth Cervical Spacer SystemChoicespine, LP201916—
+5K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+5K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc.20191043
+5K182284Tyber Medical PT Interbody SpacerTyber Medical, LLC20195—
+5K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+5K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+5K181829Velofix TLIF CageU&I Corporation20181—
+5K180519HARRIER-SA™ Lumbar Interbody SystemChoicespine, LP20180—
+6K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+6K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+6K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+6K262094E3D™-C Interbody SystemEvolution Spine20260—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+6K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+6K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+6K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+6K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+6K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+6K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+6K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K250556Porous Biologic ScaffoldVentris Medical20250—
+6K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+6K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+6K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+6K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+6K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+6K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+6K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+6K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+6K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+6K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+6K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+6K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+6K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+6K240442MagnetOs PuttyKuros Biosciences B.V20243—
+6K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+6K240458Synthetic Bone PuttyVentris Medical20242—
+6K240459Cerament Bone Void FillerBonesupport AB20240—
+6K232347MagnetOs GranulesKuros Biosciences B.V20242—
+6K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+6K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+6K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+6K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+6K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+6K232315Catalyst Bone Void FillerOssdsign AB20237—
+6K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+6K230583Tryptik TiSpineart SA20231—
+6K223418DeGen Impulse AM™ SystemDegen Medical20236—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+6K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+6K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+6K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+6K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+6K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+6K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+6K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+6K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+6K214011Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal…Medtronic Sofamor Danek USA, Inc.20221—
+6K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+6K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+6K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+6K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+6K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+6K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+6K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+6K202637F3D Corpectomy SystemCorelink, LLC20201—
+6K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—